MID LABS
Received Jan 27, 2016
Report 2935428-2016-00002 · MDR key 5401488
Device
Product problems
- Failure to Cut
- Failure to Cut
Patient
Not reported
- Vitrectomy
- Vitrectomy
Narrative
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 23G, R1, VC (MODEL 2520CE, LOT # 13061204) DID NOT WORK WHILE PATIENT WAS UNDERGOING SURGERY. FACILITY DID NOT KNOW DATE OF EVENT. PROCEDURE WAS COMPLETED, AND 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 (23 GAUGE, R1 VITREOUS CUTTER - MODEL 2520CE, LOT 13061204) WITH THE COMPLAINT "CUTTER DID NOT WORK", EXAMINATION SHOWED SOFT BEND ON NEEDLE, TIP WOBBLED WHEN ROLLED; NO OTHER ABNORMITY. THE FOLLOWING TESTS WERE CONDUCTED: ASPIRATION TEST: RESULT - PASS 150 MMHG TEST ON TESTER, NORMAL FLOW OBSERVED. TISSUE CUT TEST: RESULT - PASS 60/600 CPM TISSUE CUT TESTS. RETRACTION TEST: RESULT - PASS. LEAK TEST: RESULT - PASS 50 PSI OPEN PORT AND CLOSED PORT LEAK TESTS. DEVICE PASSED ALL MIDLABS PRODUCTION TESTING, AND IS FULLY FUNCTIONAL.