HARMONIC SCALPELS/SHEARS

Additional Manufacturer Narrative

IT WAS REPORTED THAT A PATIENT UNDERWENT A HYSTERECTOMY WITH A REPROCESSED HARMONIC SCALPELS/SHEARS AND THE BLADE TIP BROKE. THE ORIGINAL TRAYFORM PACKAGE, LABEL AND ORIGINALLY SUPPLIED TORQUE WRENCH WERE RETURNED ON 7-DEC-2021. THE RETURNED DEVICE WAS EXAMINED. THE DEVICE SERIAL NUMBER IS (B)(6) WHICH LINKS IT TO LOT 2140391. THERE IS NO OBSERVED STRUCTURAL DAMAGE TO THE HOUSING OR SHAFT OF THE DEVICE. THE DEVICE APPEARS TO BE CLEAN AND UNUSED. THE BLADE IS OBSERVED TO BE WHOLE AND INTACT. IT IS OBSERVED THAT THE BLADE TIP IS NOT BROKEN. IT IS OBSERVED THAT THE CLAMP ARM, WHILE STILL ATTACHED TO THE JAW HINGE PINS, IT IS NOT ATTACHED TO THE SLIDE LINKAGE SLOTS. UNDER MAGNIFICATION THE SLIDE LINKAGE SLOTS ARE BROKEN AND BENT BACKWARDS. IT APPEARS THE CLAMP ARM WAS FORCIBLY BENT BACKWARDS, BREAKING THE SLIDE LINKAGE SLOTS, PREVENTING THE CLAMP ARM FROM OPENING AND CLOSING. WHILE THE TISSUE PAD APPEARS IN POSITION, WHOLE AND INTACT, THE BACK CORNER OF THE PAD HAS BEEN BENT UPWARDS BY AN UNKNOWN OBJECT. WHILE THE SLIDE LINKAGE HAS BEEN DAMAGED, THE BLADE ROD AND CLAMP ARM ARE STILL ATTACHED, NOTHING IS DETACHED. THE DEVICE'S ELECTRICAL FUNCTIONALITY WAS EXAMINED. IT WAS PLUGGED INTO GENERATOR G11. THE GENERATOR NOTED IT WAS IDENTIFYING THE DEVICE AND PROCEEDED TO THE "SYSTEM READY" SCREEN AND BOTH THE MAX AND MIN BUTTONS OPERATED. THE REPORTED ISSUE OF A BROKEN BLADE IS NOT CONFIRMED. HOWEVER, THE ANALYSIS WILL ALSO CODE THE DAMAGED JAWS. AS PRODUCT WAS REMOVED FROM ITS PACKAGING AND HANDLED IN AN UNKNOWN MANNER, NO CONCLUSION IS DETERMINED AS TO WHAT MAY HAVE CAUSED THE OBSERVED DAMAGE, THOUGH THIS IS INDICATIVE OF CONTACT WITH SOME TYPE OF INSTRUMENT OR SURFACE WITH EXCESSIVE FORCE. THE DEVICE HISTORY RECORD FOR LOT 2140391 WAS REVIEWED, AND THE DEVICE PASSED ALL VISUAL AND FUNCTIONAL CRITERIA PRIOR TO BEING DISTRIBUTED TO THE CUSTOMER. A MANUFACTURING RECORD EVALUATION WAS CONDUCTED AS THERE WERE NO IDENTIFIED NON-CONFORMANCES. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. NO: (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT UNDERWENT A HYSTERECTOMY WITH A REPROCESSED HARMONIC SCALPELS/SHEARS AND THE BLADE TIP BROKE. IT WAS DESCRIBED TO HAVE LOOKED LIKE THE ENTIRE TIP OF THE JAW WAS THERE BUT THAT THE HINGE MAY HAVE BROKEN, BUT ALL CONTENTS WERE THERE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE.

Additional Manufacturer Narrative

THE DEVICE HAS NOT YET BEEN RETURNED FOR ANALYSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. (B)(4).