BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NABS SUR SUT USP MERSILK* NW5085

    MDR report key: 18066548 · Received November 3, 2023

    Report

    Report Number
    2210968-2023-08537
    Event Type
    Malfunction
    Date Received
    November 3, 2023
    Date of Event
    January 1, 2023
    Report Date
    December 7, 2023
    Manufacturer
    ETHICON INC.
    Product Code
    GAP
    PMA / PMN Number
    K946173
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). 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. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE, AND NO NON-CONFORMANCES WERE IDENTIFIED.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 11/3/2023. 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. ADDITIONAL INFORMATION WAS REQUESTED, THE FOLLOWING WAS OBTAINED: WHEN DID THE SUTURE BREAK (IN THE PACKAGE, DURING REMOVAL FROM THE PACKAGE, DURING HANDLING BEFORE USE ON PATIENT OR DURING USE ON THE PATIENT)? PLEASE SPECIFY : DURING USE ON THE PATIENT, WERE THERE ANY PATIENT CONSEQUENCES? : NO. WHAT IS THE PROCEDURE NAME? : CHOLECYSTECTOMY. PLEASE PROVIDE THE SOURCE OR NAME AND TITLE OF THE EXTERNAL PERSON PROVIDING ANSWERS TO FOLLOW-UP (EXTERNAL PERSON SUBMITTING ANSWERS TO SALES REP) OT MANAGER DEVICE RETURN STATUS? WILL UPDATE ONCE RETURNED NOTE: KINDLY PROVIDE THE SOURCE OF THE INFORMATION (I.E. INFORMATION RECEIVED FROM DR, NURSE ETC.) DR (B)(6). PLEASE PERFORM AND DOCUMENT THE FOLLOW-UP ATTEMPT FOR PRODUCT RETURN. PLEASE DOCUMENT THE SHIPMENT TRACKING NUMBER IN THE NOTES OR RMAO SECTIONS. THE FOLLOWING INFORMATION WAS RECEIVED: WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? : UNKNOWN, WAS PROCEDURE SUCCESSFULLY COMPLETED? : UNKNOWN, 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. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A CHOLECYSTECTOMY PROCEDURE IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2207904 NABS SUR SUT USP MERSILK* NW5085 SUTURE, NONABSORBABLE, SILK GAP ETHICON INC. V2007

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown