ENDO STITCH SULU

Additional Manufacturer Narrative

EVALUATION SUMMARY: POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF THREE DEVICE. DEVICE HAD BENT BLADES. DEVICE THREE WAS RETURNED LOADED WITH A NEEDLE THAT COULD NOT BE UNLOADED FROM THE DEVICE, NEEDLE WAS LOADED UPSIDE DOWN. DEVICE ONE HAD BENT BLADES. DEVICE TWO HAD A BROKEN NEEDLE PIECE LODGED IN THE RIGHT JAW. RECORDS FROM EACH MANUFACTURING LOT ARE THOROUGHLY REVIEWED TO ENSURE THAT PRODUCTS ARE RELEASED MEETING ALL QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE. ANALYSIS CONCLUDED THERE WERE NO ASSEMBLY COMPONENT RELATED FAILURES. REPLICATION OF THE BENT BLADE INDICATES THAT THE INSTRUMENT MAY HAVE BEEN EXPOSED TO AN EXTERNAL FORCE WHICH BENT THE EXPOSED METAL BARS. REPLICATION OF THE IMPROPER LOADED NEEDLE MAY OCCUR IF EITHER THE DLU OR THE ENDO STITCH SUTURING DEVICE IS HELD WITH THE PRINTED INFORMATION FACING DOWN WHEN THE NEEDLE IS LOADED IN THE DEVICE. IN THIS SITUATION, MARKS WILL OCCUR ON THE OPPOSITE SIDE THE LOADING SLOTS OF THE NEEDLE. 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 THE PROCEDURE, THE DEVICE JAMMED AND IT WOULD NOT WORK. THERE WAS NO PATIENT INVOLVEMENT.