MULTIPLE CLIP APPLIER LIGACLIP

Additional Manufacturer Narrative

IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST LUMPECTOMY WITH A REPROCESSED MULTIPLE CLIP APPLIER LIGACLIPS AND WHEN CLIP APPLIER FIRED IT DID NOT CLOSE ON TISSUE. THE RETURNED DEVICE WAS RECEIVED INSIDE A SEALED PLASTIC BIOHAZARD BAG, WITH NONE OF THE ORIGINAL PACKAGING OR LABELING RETURNED. THERE ARE NO FIRED CLIPS FROM THIS DEVICE PROVIDED AS WELL. IT WAS OBSERVED THAT THE DEVICE WAS MARKED FOR (B)(6) CLIPS BEING SENT TO THE CUSTOMER. HOWEVER, THE DEVICE HAS BEEN RETURNED WITH THE YELLOW TAB FULLY FORWARD AND THE LOCKING MECHANISM ENGAGED. THERE ARE NO REMAINING CLIPS. ALL (B)(6) CLIPS HAVE BEEN FIRED FROM THIS DEVICE. AS THERE ARE NO REMAINING CLIPS AND THE HANDLE IS LOCKED, THE FIRING CAPABILITY OF THE DEVICE CANNOT BE OBSERVED. THE JAWS OF THE DEVICE APPEAR PROPERLY SPACED AND ALIGNED. THERE ARE NO OBSERVED VISUAL DEFECTS WITH THE DEVICE. THERE WAS NO ADDITIONAL EVIDENCE PROVIDED SHOWING THE CONDITION OF THE FIRED CLIPS FROM THIS DEVICE. AS THERE WAS NO EVIDENCE OF A DEFECT WITH THIS DEVICE, THE REPORTED ISSUE WAS NOT CONFIRMED. AS PRODUCT WAS REMOVED FROM ITS PACKAGING AND WAS USED BY THE ACCOUNT, NO CONCLUSION AS TO THE CAUSE OF THE REPORTED ISSUE IS DETERMINED. THE DEVICE HISTORY RECORD OF LOT 2153586 WAS REVIEWED AND ALL FINISHED GOODS PRODUCTS REPROCESSED UNDER THIS LOT PASSED ALL VISUAL AND FUNCTIONAL CRITERIA PRIOR TO BEING DISTRIBUTED TO THE CUSTOMER. NO FAILURE WAS OBSERVED ON THE DEVICE. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. NO: (B)(4).

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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. MANUFACTURE REPORT NUMBERS 2134070-2021-00025 ARE RELATED TO THE SAME EVENT. (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST LUMPECTOMY WITH TWO REPROCESSED MULTIPLE CLIP APPLIER LIGACLIPS AND WHEN CLIP APPLIER FIRED IT DID NOT CLOSE ON TISSUE. A NEW NON-REPROCESSED DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE INTENT OF THE PROCEDURE WAS NOT ALTERED BECAUSE OF THIS EVENT. THERE WAS NO PATIENT CONSEQUENCE.