ENDO DISSECT

Additional Manufacturer Narrative

EVALUATION SUMMARY POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF ONE DEVICE. THE DEVICE WAS THEN FORWARDED TO PONCE MANUFACTURING FOR FURTHER EVALUATION. PMV OBSERVED THAT SHAFT OF DEVICE WAS BENT. PMV OBSERVED DAMAGE TO BLISTER PACKAGE OF THE DEVICE NEAR THE SHAFT AREA. 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 OBSERVED CONDITION OF BENT 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. THE ROOT CAUSE OF THE OBSERVED DAMAGE WAS MISUSE OF THE PRODUCT WHICH WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. THE REPORTED CONDITION WAS CONFIRMED. 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.

Additional Manufacturer Narrative

IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem

ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, WHEN THE DEVICE WAS OPENED FROM ITS PACKAGE, IT WAS CLOSING DIAGONALLY AS A CROSS. THE DEVICE WAS REPLACED WITH NEW ONE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.