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 PHYSICIAN STATED THAT DURING VITRECTOMY FOR INTRAOCULAR FOREIGN BODY THE CUTTER STOPPED WORKING AFTER THE FIRST CASE. FACILITY DID NOT KNOW DATE OF EVENT, NOR THE LOT NUMBER FOR THE DEVICE. THE DEVICE DESCRIPTION IS 20G, SP, VC (MODEL 2405CE, LOT # UNK). THIS IS AN EXTENDED CUTTER. PROCEDURE WAS COMPLETED AND THERE WAS 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 (20 GAUGE, SP VITREOUS CUTTER - MODEL 2405CE, LOT # NOT REPORTED) WITH THE COMPLAINT "CUTTER STOPPED WORKING", THE DEVICE WAS EXAMINED AND NO ABNORMALITIES WERE OBSERVED. EXAMINATION SHOWED THAT EPOXY APPLIED BETWEEN CAP AND NEEDLE WAS INTACT. 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 MID PRODUCTION TESTING AND IS FULLY FUNCTIONAL.