MID LABS

Additional Manufacturer Narrative

AT THIS TIME THE DEVICE HAS NOT BEEN RETURNED TO MIDLABS FOR INVESTIGATION. MIDLABS HAS MADE ATTEMPTS TO OBTAIN THE DEVICE FROM THE CUSTOMER. IF/WHEN THE DEVICE IS RECEIVED AN INVESTIGATION WILL BE PERFORMED, AND MIDLABS WILL INCLUDE THE RESULTS IN A FOLLOW-UP MEDWATCH REPORT.

Description of Event or Problem

USER FACILITY REPORTED THAT NO CUTTING FUNCTION OCCURRED WHEN PHYSICIAN ATTEMPTED TO USE 23G, R4, VC (MODEL # 2920CE, LOT # 103090902). THE PATIENT WAS UNDERGOING SURGERY. PROCEDURE WAS COMPLETED USING ANOTHER PROBE. NO PATIENT INJURY REPORTED. NO DELAY IN TREATMENT, NO MEDICAL INTERVENTION WAS REQUIRED. THE INCIDENT WAS REPORTED TO MIDLABS ON (B)(6) 2015. TO DATE, THE DEVICE HAS NOT BEEN RETURNED TO MIDLABS FOR INVESTIGATION.

Additional Manufacturer Narrative

UPON RECEIPT OF PRODUCT AT MIDLABS, IT WAS DISCOVERED THAT CUSTOMER RETURNED SEVEN (7) VITREOUS CUTTERS (23 GAUGE, R4 VITREOUS CUTTERS - MODEL 2920CE, LOT 13090902) WITH THE COMPLAINT "NO CUTTING FUNCTION OCCURRED". AN EXAMINATION OF THE DEVICE HISTORY RECORD FOR MODEL 2920CE, LOT 13090902, WAS CONDUCTED AND NO FAILURES WERE FOUND DURING THE BUILD OF THE LOT. ADDITIONALLY, CUSTOMER COMPLAINTS WERE REVIEWED FOR THE YEARS 2013, 2014, 2015, AND 2016, TO DETERMINE IF FEEDBACK FROM OTHER CUSTOMERS WAS RECEIVED WITH REGARD TO THIS PRODUCT. AT THIS TIME, NO ADDITIONAL COMPLAINTS HAVE BEEN FILED REGARDING MIDLABS 23 GAUGE, R4 VITREOUS CUTTERS (MODEL 2920CE, LOT 13090902). CUTTER #1 (MODEL 2920CE, LOT 13090902) - UPON RECEIPT OF PRODUCT AT MIDLABS, EXAMINATION SHOWED SOFT BEND ON NEEDLE, TIP WOBBLED WHEN ROLLED; NO OTHER ABNORMITY. THE FOLLOWING TESTS WERE CONDUCTED: ASPIRATION TEST: RESULT - NORMAL FLOW OBSERVED AT 150 MMHG. TISSUE CUT TEST: RESULT - PASS 60 CPM; PASS 600 CPM. RETRACTION TEST: RESULT - PASS. LEAK TEST: RESULT - PASS 50 PSI AND CUT LEAK TESTS. PROBE PASSED ALL MIDLABS PRODUCTION TESTING, AND IS FULLY FUNCTIONAL. (B)(4). CUTTER #2 (MODEL 2920CE, LOT 13090902) - UPON RECEIPT OF PRODUCT AT MIDLABS, ONLY PROBE WAS RETURNED BY CUSTOMER. CUSTOMER DID NOT RETURN NEEDLE AND CUTTER. EXAMINATION SHOWED NEEDLE AND CUTTER WERE BROKEN OFF AT NEEDLE-BODY JOINT. THE FOLLOWING TESTS WERE CONDUCTED: ASPIRATION TEST: RESULT - COULD NOT BE COMPLETED AS NEEDLE AND CUTTER WERE NOT RETURNED. TISSUE CUT TEST: RESULT - COULD NOT BE COMPLETED AS NEEDLE AND CUTTER WERE NOT RETURNED. RETRACTION TEST: RESULT - COULD NOT BE COMPLETED AS NEEDLE AND CUTTER WERE NOT RETURNED. LEAK TEST: RESULT - PASS 50 PSI AND OPEN PORT LEAK TEST. DISSECTION: RESULT - CUTTER AND NEEDLE APPEAR TO HAVE BEEN BENT CAUSING BOTH TO BREAK OFF. AS PROBE WAS RETURNED WITHOUT NEEDLE AND CUTTER, INVESTIGATOR WAS UNABLE TO PROCEED WITH ROUTINE PRODUCTION TESTS (SEE ABOVE). MIDLABS VISUALLY INSPECTS PROBES FOR BENDS PRIOR TO SHIPMENT TO CUSTOMER. PROBE NOT RETURNED IN ORIGINAL PACKAGING. CUSTOMER TOOK NO CARE TO SHIP PRODUCT BACK TO MIDLABS. (B)(4). CUTTER #3 (MODEL 2920CE, LOT 13090902) - UPON RECEIPT OF PRODUCT AT MIDLABS, EXAMINATION SHOWED NEEDLE SEVERELY BENT AT TIP; NO OTHER ABNORMITY. THE FOLLOWING TESTS WERE CONDUCTED: ASPIRATION TEST: RESULT - NORMAL FLOW OBSERVED AT 150 MMHG. TISSUE CUT TEST: RESULT - COULD NOT BE COMPLETED AS NEEDLE IS SEVERELY BENT AT TIP. RETRACTION TEST: RESULT - COULD NOT BE COMPLETED AS NEEDLE IS SEVERELY BENT AT TIP. LEAK TEST: RESULT - PASS 50 PSI AND OPEN PORT LEAK TEST. PROBE WAS RECEIVED WITH THE NEEDLE AND CUTTER HAVING A SEVERE CURVED/SHARP BEND WHICH CAUSES BINDING BETWEEN THE CUTTER AND NEEDLE, AND RENDERS THE PROBE INOPERABLE. PROBABLE CAUSE WAS DUE TO SHIPMENT FROM CUSTOMER SITE BACK TO MIDLABS. AS A RESULT, INVESTIGATOR WAS UNABLE TO PROCEED WITH SOME ROUTINE PRODUCTION TESTS (SEE ABOVE). MIDLABS VISUALLY INSPECTS PROBES FOR BENDS PRIOR TO SHIPMENT TO CUSTOMER. PROBE NOT RETURNED IN ORIGINAL PACKAGING. CUSTOMER TOOK NO CARE TO SHIP PRODUCT BACK TO MIDLABS. (B)(4). CUTTER #4 (MODEL 2920CE, LOT 13090902) - UPON RECEIPT OF PRODUCT AT MIDLABS, ONLY PROBE WAS RETURNED BY CUSTOMER. CUSTOMER DID NOT RETURN NEEDLE AND CUTTER. EXAMINATION SHOWED NEEDLE AND CUTTER WERE BROKEN OFF AT NEEDLE-BODY JOINT. THE FOLLOWING TESTS WERE CONDUCTED: ASPIRATION TEST: RESULT - NORMAL FLOW OBSERVED AT 150 MMHG. TISSUE CUT TEST: RESULT - COULD NOT BE COMPLETED AS NEEDLE IS SEVERELY BENT AT NEEDLE-BODY JOINT. RETRACTION TEST: RESULT - COULD NOT BE COMPLETED AS NEEDLE IS SEVERELY BENT AT NEEDLE-BODY JOINT. LEAK TEST: RESULT - PASS 50 PSI AND OPEN PORT LEAK TEST. AS PROBE WAS RETURNED WITHOUT NEEDLE AND CUTTER, INVESTIGATOR WAS UNABLE TO PROCEED WITH ROUTINE PRODUCTION TESTS (SEE ABOVE). MIDLABS VISUALLY INSPECTS PROBES FOR BENDS PRIOR TO SHIPMENT TO CUSTOMER. PROBE NOT RETURNED IN ORIGINAL PACKAGING. CUSTOMER TOOK NO CARE TO SHIP PRODUCT BACK TO MIDLABS. (B)(4). CUTTER #5 (MODEL 2920CE, LOT 13090902) - UPON RECEIPT OF PRODUCT AT MIDLABS, EXAMINATION SHOWED NEEDLE SEVERELY BENT; NO OTHER ABNORMITY. THE FOLLOWING TESTS WERE CONDUCTED: ASPIRATION TEST: RESULT - NORMAL FLOW OBSERVED AT 150 MMHG. TISSUE CUT TEST: RESULT - PASS 60 CPM; PASS 600 CPM. RETRACTION TEST: RESULT - CUTTER STUCK AT PORT (FULLY CLOSED) DURING RETRACTION TEST. LEAK TEST: RESULT - PASS 50 PSI AND OPEN AND CLOSED PORT LEAK TESTS. PROBE WAS RECEIVED WITH THE NEEDLE AND CUTTER HAVING A PERMANENT BEND, WHICH CAUSED ADDITIONAL FRICTION BETWEEN THE CUTTER AND NEEDLE. THIS PREVENTS THE CUTTER FROM GOING THROUGH ITS FULL TRAVEL CAUSING THE "NO TOUCH" RETRACTION FAILURE OBSERVED. MIDLABS VISUALLY INSPECTS PROBES FOR BENDS PRIOR TO SHIPMENT TO CUSTOMER. PROBE NOT RETURNED IN ORIGINAL PACKAGING. CUSTOMER TOOK NO CARE TO SHIP PRODUCT BACK TO MIDLABS. (B)(4). CUTTER #6 (MODEL 2920CE, LOT 13090902) - UPON RECEIPT OF PRODUCT AT MIDLABS, EXAMINATION SHOWED SOFT BEND ON NEEDLE, TIP WOBBLED WHEN ROLLED; NO OTHER ABNORMITY. THE FOLLOWING TESTS WERE CONDUCTED: ASPIRATION TEST: RESULT - NORMAL FLOW OBSERVED AT 150 MMHG. TISSUE CUT TEST: RESULT - PASS 60 CPM; PASS 600 CPM. RETRACTION TEST: RESULT - PASS. LEAK TEST: RESULT - PASS 50 PSI OPEN PORT AND CLOSED PORT LEAK TESTS. PROBE PASSED ALL MIDLABS PRODUCTION TESTING, AND IS FULLY FUNCTIONAL. (B)(4). CUTTER #7 (MODEL 2920CE, LOT 13090902) - UPON RECEIPT OF PRODUCT AT MIDLABS, EXAMINATION SHOWED SOFT BEND ON NEEDLE, TIP WOBBLED AND NEARLY TOUCHING SURFACE WHEN ROLLED; NO OTHER ABNORMITY. THE FOLLOWING TESTS WERE CONDUCTED: ASPIRATION TEST: RESULT - NORMAL FLOW OBSERVED AT 150 MMHG. TISSUE CUT TEST: RESULT - PASS 60 CPM; PASS 600 CPM. RETRACTION TEST: RESULT - CUTTER STUCK AT PORT FULLY CLOSED POSITION. LEAK TEST: RESULT - PASS 50 PSI OPEN PORT AND CLOSED PORT LEAK TESTS. DISSECTION: RESULT - NORMAL SUB-ASSEMBLIES; KINK ON CUTTER; SEVERE DRAG DURING CUTTER EXTRACTION. PROBE WAS RECEIVED WITH NEEDLE AND CUTTER HAVING A PERMANENT BEND WHICH CAUSED ADDITIONAL FRICTION BETWEEN THE CUTTER AND THE NEEDLE. THIS PREVENTS THE CUTTER FROM GOING THROUGH ITS FULL TRAVEL CAUSING THE "NO TOUCH" RETRACTION FAILURE OBSERVED. MIDLABS VISUALLY INSPECTS PROBES FOR BENDS PRIOR TO SHIPMENT TO CUSTOMER. PROBE NOT RETURNED IN ORIGINAL PACKAGING. CUSTOMER TOOK NO CARE TO SHIP PRODUCT BACK TO MIDLABS. (B)(4).