MID LABS

Additional Manufacturer Narrative

UPON RECEIPT OF PRODUCT AT MIDLABS (23 GAUGE, R3 VITREOUS CUTTER - MODEL 2720CE, LOT 13100901) WITH THE COMPLAINT "VITREOUS CUTTER STOPPED FUNCTIONING AFTER COMING INTO CONTACT WITH METALLIC FOREIGN BODY", EXAMINATION SHOWED SOFT BEND ON NEEDLE, TIP WOBBLED WHEN ROLLED, HAIRLINE CRACKS OBSERVED ON EPOXY BEAD, OVER BITE TRACE AND A SMALL DENT OBSERVABLE ON NEEDLE CUTTING EDGE, CUTTER EDGE DULL AND EVEN. THE FOLLOWING TESTS WERE CONDUCTED: ASPIRATION TEST: RESULT - NO FLOW; CLOG REMOVED WITH WIRE FLUSH. TISSUE CUT TEST: RESULT - 60 CPM TEAR TO NO CUTS; SLOW TO CUT UNTIL AFTER CLOG REMOVED; PASS 600 CPM, PASS 8000 CPM WITH ASP. RETRACTION TEST: RESULT - PASS. LEAK TEST: RESULT - PASS 50 PSI OPEN PORT AND CLOSED PORT LEAK TESTS. PROBE ASPIRATION PATH WAS CLOGGED BY METAL PARTICLE WHICH WAS IN THE PATIENT'S EYE PRIOR TO PROCEDURE. DAMAGE OBSERVED ON BOTH NEEDLE PORT AND CUTTER CUTTING EDGES, AS WELL PROBE NEEDLE RECEIVED WITH PERMANENT BEND, ALL OF WHICH MAY CAUSE THE PROBE TO CUT INEFFICIENTLY OR STOP CUTTING ALTOGETHER. NO PATIENT INJURY REPORTED BY USER FACILITY.

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 PHYSICIAN STATED THAT DURING VITRECTOMY FOR INTRAOCULAR FOREIGN BODY THE CUTTER STOPPED FUNCTIONING AFTER COMING INTO CONTACT WITH METALLIC FOREIGN BODY. THE DEVICE DESCRIPTION IS 23G, R3+, VC (MODEL 2720CE, LOT # 13100901). PROCEDURE WAS COMPLETED, AND NO PATIENT INJURY REPORTED. NO DELAY IN TREATMENT, NO MEDICAL INTERVENTION REQUIRED. THE INCIDENT WAS REPORTED TO MIDLABS ON (B)(4) 2015. TO DATE, THE DEVICE HAS NOT BEEN RETURNED TO MIDLABS FOR INVESTIGATION.