BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEV GN BR 0 TC-43/HR26 2N 36"

    MDR report key: 11222774 · Received January 25, 2021

    Report

    Report Number
    3004365956-2021-00031
    Event Type
    Malfunction
    Date Received
    January 25, 2021
    Date of Event
    November 28, 2020
    Report Date
    December 28, 2020
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GAT
    PMA / PMN Number
    K021019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4), NO ISSUES OR DISCREPANCIES WERE FOUND IN THE DEVICE HISTORY RECORD OF PRODUCT CODE 833-114 / BATCH 74C1902280 THAT CAN BE RELATED TO THE FAILURE MODE REPORTED. PER HA-000039 REV. 12 LINE: OPERATIONAL HAZARDS - INCORRECT OR INAPPROPRIATE OUTPUT OR FUNCTIONALITY - NEEDLE DISENGAGES/SEPARATES FROM SUTURE WHEN USED WITH AN ACCESSORY AND/OR SUTURING DEVICE: WHEN THE SUTURE IS USED WITH AN ACCESORY AND/OR SUTURING DEVICE THE SUTURE MAYBE SUBJECT TO FORCES THAT ARE UNDER CONTROL OF THE SURGEON USING THE DEVICE. A CORRECTIVE ACTION CANNOT BE DETERMINED DUE TO THE LACK OF BATCH NUMBER TO PERFORM A PROPER INVESTIGATION AND DETERMINE A ROOT CAUSE. CUSTOMER COMPLAINT CANNOT BE CONFIRMED BASED ONLY ON THE INFORMATION PROVIDED, TO PERFORM AN INVESTIGATION AND DETERMINE THE SOURCE OF DEFECT REPORTED IT IS NECESSARY TO EVALUATE THE SAMPLE INVOLVED ON THIS COMPLAINT. AN ATTEMPT TO DUPLICATE THE FAILURE MODE WAS MADE BUT AT THE TIME THERE IS NO INVENTORY OF THE INVOLVED PRODUCT CODE AVAILABLE AT THE FACILITY NOR IS BEING MANUFACTURED AT THE TIME. IF THE SAMPLE BECOMES AVAILABLE THIS INVESTIGATION WILL BE UPDATED WITH THE EVALUATION RESULTS.

    Description of Event or Problem · 0

    DURING SACROSPINOUS FIXATION THE BULLET AT THE TIP OF THE SUTURE GOT STUCK IN THE CAPIO SLIM WHILE PUSHING THE HANDLE OF THE CAPIO. THIS EVENT HAPPENED SEVERAL TIMES AND FINALLY, SHE HAD TO USE ANOTHER CAPIO SLIM TO SOLVE THE PROBLEM.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

    Description of Event or Problem · 1

    DURING SACROSPINOUS FIXATION THE BULLET AT THE TIP OF THE SUTURE GOT STUCK IN THE CAPIO SLIM WHILE PUSHING THE HANDLE OF THE CAPIO. THIS EVENT HAPPENED SEVERAL TIMES AND FINALLY, SHE HAD TO USE ANOTHER CAPIO SLIM TO SOLVE THE PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119739 TEV GN BR 0 TC-43/HR26 2N 36" SUTURE, NONABSORBABLE, SYNTHE GAT TELEFLEX MEDICAL 74C1902280

    Patients

    Seq Age Sex Outcome Treatment
    1