LIGAMAX

Description of Event or Problem

IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE AND DURING THE FOURTH FIRING, THE CLIP DID NOT COME OUT. WHEN ATTEMPTING THE FIFTH FIRING, THE JAWS CRACKED AND THE TIP DID NOT OPEN. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

Additional Manufacturer Narrative

(B)(4). DATE SENT: 7/7/2026. D4 BATCH # UNK. ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. THE MANUFACTURING RECORDS WERE REVIEWED AND THE MANUFACTURING/PACKAGING CRITERIA WERE MET PRIOR TO THE RELEASE OF THIS LOT. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT: WAS THE DEVICE ON A VESSEL/ARTERY WHEN IT WOULD NOT OPEN? IF YES, HOW WAS THE DEVICE REMOVED? (CUT OFF, FORCED OPEN) IF THE DEVICE WAS CUT OFF, WAS THERE ANY DAMAGE TO THE VESSEL/TISSUE? IF YES, HOW WAS THE DAMAGE ADDRESSED/REPAIRED? WERE THE DEVICE JAWS EVENTUALLY OPENED? WERE THERE ANY PATIENT CONSEQUENCES? THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.