HARMONIC SCALPELS/SHEARS

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT UNDERWENT A HYSTERECTOMY PROCEDURE WITH A REPROCESSED HARMONIC SCALPELS/SHEARS AND THE DISTAL TIP DETACHED FROM THE DEVICE. THE DETACHED PIECE WAS RECOVERED FROM THE PATIENT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE.

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. MANUFACTURER'S REF. NO: (B)(4).

Additional Manufacturer Narrative

IT WAS REPORTED THAT A PATIENT UNDERWENT A HYSTERECTOMY PROCEDURE WITH A REPROCESSED HARMONIC SCALPELS/SHEARS AND THE DISTAL TIP DETACHED FROM THE DEVICE. THE DETACHED PIECE WAS RECOVERED FROM THE PATIENT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE. THE HAR36R DEVICE WAS RETURNED SEALED INSIDE A BIOHAZARD BAG ALONG WITH THE TRAY FORM'S PRIMARY LABEL. NONE OF THE REMAINING ORIGINAL PACKAGING WAS RETURNED. THE DEVICE SERIAL NUMBER IS (B)(6) WHICH LINKS THE DEVICE TO LOT 2166506. A VISUAL INSPECTION OF THE DEVICE WAS CONDUCTED. THERE WAS NO OBSERVED STRUCTURAL DAMAGE TO THE HOUSING OR SHAFT OF EITHER DEVICE. THE BUTTONS APPEAR TO WORK NORMALLY. THERE WERE OBSERVED BIOLOGICAL CONTAMINANTS EMBEDDED WITHIN THE GROOVES OF THE TISSUE PAD. THE METAL ROD (THE ANVIL) WAS OBSERVED WHOLE AND INTACT. NO PART OF THE METAL ROD WAS BROKEN OR DETACHED. NO PART OF THE DEVICE WAS OBSERVED TO BE BROKEN OFF OR DETACHED. THE ENTIRE DEVICE WAS WHOLE AND INTACT. THE REPORTED ISSUE OF A BROKEN TIP COMPLETELY DETACHING FROM THE DEVICE, INSIDE THE PATIENT, WAS NOT VERIFIED OR CONFIRMED. THE CLAMP ARM WITH THE TISSUE PAD WAS NOT CONNECTED PROPERLY TO THE SLIDE LINKAGE HOLE. THE CLAMP ARM WAS STILL ATTACHED TO THE DEVICE, BUT SINCE IT WAS NOT PROPERLY CONNECTED TO THE SLIDE LINKAGE, THE JAWS WOULD NOT OPEN OR CLOSE. THE SLIDE LINKAGE HOLE WAS OBSERVED TO BE DAMAGED AND BENT, INDICATIVE OF EXCESSIVE FORCE THAT WOULD PUSH THE CLAMP ARM OUT OF THE SLIDE LINKAGE HOLE. THE HOLES, THOUGH BENT, ARE STILL INTACT AND THE CLAMP ARM RECONNECTED INTO THE SLIDE LINKAGE. THE OBSERVED DISCONNECTED CLAMP ARM WAS UNRELATED TO THE REPORTED ISSUE. AS THE DEVICE WAS REMOVED FROM ITS PACKAGING AND WAS HANDLED WITHIN THE OPERATIVE FIELD, NO CONCLUSION AS TO THE CAUSE FOR THE REPORTED ISSUE, OR FOR THE OBSERVED DAMAGE WAS DETERMINED. THE DEVICE HISTORY RECORD FOR LOT 2166506 WAS REVIEWED AND THE DEVICE (ID (B)(6)) WAS NOTED TO HAVE PASSED ALL VISUAL AND FUNCTIONAL CRITERIA PRIOR TO BEING SHIPPED TO THE CUSTOMER. A MANUFACTURING RECORD EVALUATION WAS CONDUCTED AND THERE WERE NO IDENTIFIED INTERNAL ACTIONS. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. NO: (B)(4).