ENDO DISSECT

Additional Manufacturer Narrative

EVALUATION SUMMARY: POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF ONE DEVICE. PMV OBSERVED THAT SHAFT OF DEVICE WAS BENT. JAWS OF DEVICE WAS DAMAGED AND MISALIGNED. A REVIEW OF THE DEVICE HISTORY RECORD INDICATES THE PRODUCT WAS RELEASED MEETING ALL QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE. REPLICATION OF THE REPORTED CONDITION OF DEFORMED SHAFT IN SEALED DEVICE PACKAGE MAY OCCUR DUE TO INADEQUATE HANDLING AND SHIPPING OF THE UNITS AFTER THEY ARE REMOVED FROM THE PACKAGING BOX. WHERE BENDING FORCES ACTING ON THE PACKAGE ALONG THE SHAFT AREA WOULD RESULT IN THE OBSERVED CONDITION. REPLICATION OF DAMAGED AND MISALIGNED JAWS MAY OCCUR WHEN THE DEVICE SHAFT IS DEFORMED TO A SEVERITY WHICH CAUSES A SUBSEQUENT CHANGE TO WHERE THE JAW ATTACHES, THIS IN TURNS CHANGES THE CONFIGURATION OF JAWS AND MISALIGNMENT IS OBSERVED. THE ROOT CAUSE OF THE OBSERVED DAMAGE WAS MISUSE OF THE PRODUCT WHICH WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. SHOULD NEW INFORMATION BECOME AVAILABLE, THE FILE WILL BE RE-OPENED AND THE INVESTIGATION SUMMARY WILL BE AMENDED AS APPROPRIATE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem

ACCORDING TO THE REPORTER, PRIOR TO A LAPAROSCOPIC PROCEDURE, THE TIP/END PARTS OF THE DEVICE DID NOT COME ACROSS. THE PROBLEM WAS SEEN WHILE OPENING THE DEVICES FROM THE STERILE PACKAGE THAT THE TIPS DID NOT OVERLAP EACH OTHER. THE DEVICE WHICH WAS TAKEN FROM THE STERILE PACKAGE WAS DEFECTIVE, WHEREIN IT HAD VISIBLE DEFORMATION. IT WAS NOTED THAT DEFECT WAS OBSERVED WITH 12 DEVICES WHICH ARE IN THE SAME STERILE PACKAGE. THE DEVICES WERE NOT USED IN THE PATIENT FOR THE PATIENT SAFETY.