SCISSORS INSERT METZENBAUM DISPOSABLE

Additional Manufacturer Narrative

IT WAS REPORTED THAT DURING PRE-OP FOR A PROCEDURE, THE REPROCESSED SCISSORS INSERT METZENBAUM DISPOSABLE PACKAGING CONTAMINATED THE DEVICE AND BECAME UNSTERILE. THE PACKAGE AND DEVICE WERE RECEIVED. THE CHEVRON SIDE, SEALED BY THE PACKAGING OEM, IS THE SECTION THAT HAS BEEN OPENED BY THE HANDLER. THE STERILMED SEALED PART OF THE PACKAGE REMAINS SEALED AND IS NOT AFFECTED. IT IS OBSERVED THAT THE ORIGINAL EQUIPMENT MANUFACTURER SEAL HAS BEEN PULLED APART IN AN IRREGULAR MANNER, STARTING AT THE LEFT EDGE OF THE CHEVRON, RATHER THAN THE CENTER. EXCESSIVE PULL FORCE HAS BEEN APPLIED TO THE LEFT-SIDE OF THE PACKAGE'S SEAL, SHEARING INTO THE TYVEK MATERIAL. THE PULL EXTENDS 12 INCHES DOWN THE LEFT SIDE OF THE SEAL, COMPARED TO THE RIGHT-SIDE SEAL, PULLED DOWN ONLY 11 INCHES, WITH NO VISIBLE SHEARING OBSERVED. WHILE THERE ARE NO OBSERVED LOOSE FRAGMENTS, FIBERS OR FOREIGN MATTER ON THE RETURNED DEVICE, OPENING A PACKAGE INCORRECTLY COULD COMPROMISE THE STERILITY OF THE CONTENTS. THE PACKAGING WAS DAMAGED UPON ITS OPENING. PURCHASED PACKAGING IS INSPECTED BY THE SUPPLIER, AND A CERTIFICATE OF COMPLIANCE IS SENT WITH EACH SHIPMENT. THE DEVICE HISTORY RECORD OF LOT 2130477 (MANUFACTURING DATE 01/20/2021) WAS REVIEWED AND THE DEVICE AND PACKAGING PASSED ALL VISUAL INSPECTION CRITERIA PRIOR TO DISTRIBUTION TO THE CUSTOMER. A MANUFACTURING RECORD EVALUATION WAS CONDUCTED AND THERE WERE NO IDENTIFIED NONCONFORMANCES. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. NO: (B)(4).

Additional Manufacturer Narrative

THE PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. MANUFACTURER'S REF. NO: (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT DURING PRE-OP FOR A PROCEDURE, THE REPROCESSED SCISSORS INSERT METZENBAUM DISPOSABLE PACKAGING CONTAMINATED THE DEVICE AND BECAME UNSTERILE. THE DEVICE NEVER CAME IN CONTACT WITH THE PATIENT AND THERE WAS NO PATIENT CONSEQUENCE OR INJURY.