BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETHIBOND EXCEL GRN 110CM M3.5

    MDR report key: 18695344 · Received February 13, 2024

    Report

    Report Number
    2210968-2024-01273
    Event Type
    Malfunction
    Date Received
    February 13, 2024
    Date of Event
    January 30, 2024
    Report Date
    October 24, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    PMA / PMN Number
    K946173
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 5/20/2024. ADDITIONAL INFORMATION: G1. ADDITIONAL INFORMATION: D4, H4 - THE ACTUAL DEVICE BATCH NUMBER ASSOCIATED WITH THIS EVENT IS NOT KNOWN. THE POSSIBLE BATCH NUMBERS ARE REPORTED AS FOLLOWS: BATCH TLMPXQ EXP. DATE: SEP/30/2028 DATE OF MFG.: OCT/19/2023. BATCH TLMUXH EXP. DATE: SEP/30/2028 DATE OF MFG.: OCT/31/2023. BATCH TCMCLK EXP. DATE: FEB/29/2028 DATE OF MFG.: MAR/7/2023. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE TCMCLK / XAEC11 BATCH NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE TLMUXH / XAEC11 BATCH NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE TLMPXQ/ XAEC11 BATCH NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. ADDITIONAL INFORMATION WAS REQUESTED, THE FOLLOWING WAS OBTAINED: EVENT #1 (CAPTURED IN (B)(4)): 1. PLEASE CONFIRM THE QUANTITY OF NEEDLES THAT PULLED OFF THE SUTURE DURING INSERTING INTO THE TROCAR; UNK IN TOTAL 5 FOR BOTH COMPLAINTS. 2. PLEASE PROVIDE ALL USED LOT NO. FOR PRODUCT CODE EC11: LOT TLMPXQ / TCMCLK / TLMUXH NOT WHICH IN WHICH COMPLAINT. 3. WAS X RAY REQUIRED FOR THIS EVENT? YES. 4. PROCEDURE NAME: HIATOPLASTIK BZW. NETZ AM HIATUS FIXIERT. EVENT #2 (CAPTURED IN (B)(4)): 1. PLEASE CONFIRM THE QUANTITY OF NEEDLES THAT PULLED OFF THE SUTURE DURING INSERTING INTO THE TROCAR; UNK IN TOTAL 5 FOR BOTH COMPLAINTS. 2. PLEASE PROVIDE ALL USED LOT NO. FOR PRODUCT CODE EC11: LOT TLMPXQ / TCMCLK / TLMUXH NOT WHICH IN WHICH COMPLAINT. 3. WAS X RAY REQUIRED FOR THIS EVENT? NO. 4. PROCEDURE NAME: FUNDOPLICATION. 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 INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC 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.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 2/13/2024. H6 COMPONENT CODE: G07002 - DEVICE NOT RETURNED. 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 INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC 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. THE LOT/BATCH WAS NOT PROVIDED; THEREFORE, A MANUFACTURING RECORD EVALUATION COULD NOT BE PERFORMED. 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: PLEASE PROVIDE THE LOT NUMBER: PLEASE PERFORM AND DOCUMENT THE FOLLOW UP ATTEMPT FOR PRODUCT RETURN. PLEASE DOCUMENT THE SHIPMENT TRACKING NUMBER IN NOTES OR RMAO SECTIONS. PLEASE PROVIDE THE SOURCE OR NAME OF PERSON PROVIDING ANSWERS TO FOLLOW-UP QUESTIONS (NOT THE PERSON RELAYING/SUBMITTING ANSWERS TO LOC OR CHU). ADDITIONAL INFORMATION WAS REQUESTED, THE FOLLOWING WAS OBTAINED: PLEASE CONFIRM THE QUANTITY OF NEEDLES THAT PULLED OFF THE SUTURE PREMATURELY: WHEN WERE THE NEEDLE PULL OFF THE SUTURE PREMATURELY (IN THE PACKAGE, DURING REMOVAL FROM PACKAGE, DURING HANDLING PRIOR TO USE ON PATIENT OR DURING USE ON THE PATIENT)? PLEASE SPECIFY. WAS THERE ANY ADVERSE CONSEQUENCE ASSOCIATED WITH THE PATIENT? WERE THERE ANY UNEXPECTED OUTCOMES OR COMPLICATIONS AS A RESULT OF THE PROLONGED SURGERY TIME? WHAT TISSUE WAS BEING SUTURED WHEN THE EVENT OCCURRED? WAS ADDITIONAL DISSECTION REQUIRED IN OTHER ORGANS/TISSUES OTHER THAN THE TARGET TISSUE? WAS THERE ANY CHANGE IN THE PATIENT¿S POST OPERATIVE CARE DUE TO THE PROLONGED PROCEDURE? SO THERE WERE 5 SUTURES IN 2 DAYS! THE NEEDLES CAME OFF WHEN THEY WERE INSERTED INTO THE TROCAR, PARTLY OUTSIDE AND PARTLY IN THE SITE - BEFORE SUTURING. THE OPERATING THEATRE TIME WAS OF COURSE EXTENDED BY THE SEARCH - IN ONE CASE WE HAD TO X-RAY, BUT IN THE END WE FOUND ALL THE NEEDLES! THE POSTERIOR HIATOPLASTY WAS SUTURED, OR A MESH WAS FIXED TO THE HIATUS, OR THE FUNDOPLICATION WAS SUTURED! NO CHANGE P.O., NO FURTHER PREPARATION INTRAOPERATIVELY! THE FOLLOWING INFORMATION WAS RECEIVED: WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? YES, IF YES, NUMBER OF MINUTES: 30 , ACTION TAKEN WHEN EVENT OCCURRED? WITH X-RAY (C ARM) THEY REMOVED THE NEEDLE FORM THE SITU. WAS PROCEDURE SUCCESSFULLY COMPLETED? YES, WERE FRAGMENTS GENERATED? UNKNOWN, IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? UNKNOWN, PATIENT STATUS/ OUTCOME / CONSEQUENCES , WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY, UNKNOWN. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. 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. PLEASE PROVIDE DETAILED INFORMATION FOR EACH EVENT: EVENT #1 (CAPTURED IN (B)(4)): 1. PLEASE CONFIRM THE QUANTITY OF NEEDLES THAT PULLED OFF THE SUTURE DURING INSERTING INTO THE TROCAR 2. PLEASE PROVIDE ALL USED LOT NO. FOR PRODUCT CODE EC11: 3. WAS X RAY REQUIRED FOR THIS EVENT? 4. PROCEDURE NAME: EVENT #2 (CAPTURED IN (B)(4)): 1. PLEASE CONFIRM THE QUANTITY OF NEEDLES THAT PULLED OFF THE SUTURE DURING INSERTING INTO THE TROCAR 2. PLEASE PROVIDE ALL USED LOT NO. FOR PRODUCT CODE EC11: 3. WAS X RAY REQUIRED FOR THIS EVENT? 4. PROCEDURE NAME: 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. RELATED REPORTS: 2210968-2024-01270, 2210968-2024-01271, 2210968-2024-01272, 2210968-2024-01274.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A NISSEN FUNDOPLICATION PROCEDURE ON (B)(6)2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE PULLED OFF THE SUTURE PREMATURELY. THIS HAPPENED SEVERAL TIMES WITH SEVERAL SUTURES FROM DIFFERENT BATCHES. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2277988 ETHIBOND EXCEL GRN 110CM M3.5 SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown