LIGACLIP*ENDO MED/LG APPLIER

Additional Manufacturer Narrative

(B)(4). DATE SENT: 4/30/2025. D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE. D4: UDI: THE EXPIRATION DATE IS CURRENTLY NOT AVAILABLE. THEREFORE, THE FULL UDI IS CURRENTLY NOT AVAILABLE. D4: UDI: THE MANUFACTURING DATE IS CURRENTLY NOT AVAILABLE. THEREFORE, THE FULL UDI IS CURRENTLY NOT AVAILABLE. D4: BATCH#: UNK. 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: "IS THE CURRENT PATIENT STATUS KNOWN? WAS THERE ANY PATIENT CONSEQUENCE OR CHANGE IN THE POST-OPERATIVE CARE OF THE PATIENT AS A RESULT OF THE EVENT? (EXTENDED HOSPITAL STAY, READMISSION, RE-OPERATION, ETC.)." THIS IS AN ANALYSIS OF TWO PHOTOS SUBMITTED TO ETHICON ENDO SURGERY FOR EVALUATION. DURING THE VISUAL ANALYSIS, THE FOLLOWING WAS OBSERVED: THE PHOTOS SHOWS A DEVICE FROM JAWS AREA AND ONE OF THE JAWS APPEARS TO BE MISALIGNED. BASED ON THE PHOTO THE EVENT DESCRIBED IS CONFIRMED, HOWEVER NO CONCLUSION OR ROOT CAUSE COULD BE DETERMINED. HANDS ON DEVICE ANALYSIS MAY PROVIDE THE ADDITIONAL EVIDENCE NECESSARY TO CONFIRM THE ROOT CAUSE OF THE REPORTED EVENT. BECAUSE THE INSTRUMENT WAS NOT RETURNED OUR EVALUATION IS LIMITED. WE VALUE THE OPPORTUNITY TO FULLY ANALYZE THE INSTRUMENT UPON ITS RETURN. AN EVALUATION OF THE MANUFACTURING RECORD COULD NOT BE PERFORMED AS THE REQUIRED PRODUCT IDENTIFICATION NUMBER WAS NOT PROVIDED TO COMPLETE THE EVALUATION. 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.

Description of Event or Problem

IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, HANDPIECE IS TWISTED AND NOT ALIGNED.

Additional Manufacturer Narrative

(B)(4). DATE SENT: 5/15/2025. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: IS THE CURRENT PATIENT STATUS KNOWN? ANSWER: THE QUALITY REPORT WAS NOT SUBMITTED DURING A SURGICAL PROCEDURE BUT RATHER AFTER THE DEVICE ARRIVED AT THE STERILIZATION CENTER. -WAS THERE ANY PATIENT CONSEQUENCE OR CHANGE IN THE POST-OPERATIVE CARE OF THE PATIENT AS A RESULT OF THE EVENT? (EXTENDED HOSPITAL STAY, READMISSION, RE-OPERATION, ETC.). ANSWER: NO CONSEQUENCE FOR ANY PATIENT ARE REPORTED, THE QUALITY REPORT WAS NOT SUBMITTED DURING A SURGICAL PROCEDURE BUT RATHER AFTER THE DEVICE ARRIVED AT THE STERILIZATION CENTER.