BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUT CHR UD 18IN 6-0 S/A G-1 PRM

    MDR report key: 9750867 · Received February 25, 2020

    Report

    Report Number
    2210968-2020-01460
    Event Type
    Malfunction
    Date Received
    February 25, 2020
    Report Date
    January 31, 2020
    Manufacturer
    ETHICON INC.
    Product Code
    GAL
    UDI-DI
    10705031011946
    PMA / PMN Number
    K946173
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE MM6533 BATCH NUMBER, AND NO NON-CONFORMANCES RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. ATTEMPTS ARE BEING 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. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: PLEASE VERIFY THE ISSUE; WERE SUTURE THREADS BREAKING? SPECIFIC NUMBER OF DEVICES THAT FAILED IN THIS PROCEDURE? WHEN DID EACH DEVICE FAIL; IN THE PACKAGE/ DURING HANDLING (BEFORE USE ON PATIENT)/DURING ACTUAL SUTURING(USE ON PATIENT) HOW WAS CASE COMPLETED? PLEASE PROVIDE THE STATUS OF THE DEVICE(S) AS IT HAS NOT BEEN RECEIVED FOR ANALYSIS. THE SUTURES WERE BREAKING EVERY TIME WE TRIED TO TIE A KNOT. WE HAD ABOUT 15 SUTURES BREAK OPENING NEW BOXES AS WELL. THEY WOULD BREAK DURING SURGERY. WE USED DIFFERENT SUTURES. NOTE: EVENTS REPORTED VIA MW # 2210968-2019-88929, 2210968-2020-01449, 2210968-2020-01450, 2210968-2020-01451, 2210968-2020-01452, 2210968-2020-01453, 2210968-2020-01454, 2210968-2020-01455, 2210968-2020-01456, 2210968-2020-01457, 2210968-2020-01458, 2210968-2020-01459, 210968-2020-01461, 2210968-2020-01462.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURES KEPT TEARING WHEN TRYING TO TIE A KNOT. A DIFFERENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213418 GUT CHR UD 18IN 6-0 S/A G-1 PRM SUTURE, ABSORBABLE, NATURAL GAL ETHICON INC. 796G MM6533 10705031011946

    Patients

    Seq Age Sex Outcome Treatment
    1