BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILS 29MM, CURVED

    MDR report key: 11285404 · Received February 5, 2021

    Report

    Report Number
    3005075853-2021-00709
    Event Type
    Malfunction
    Date Received
    February 5, 2021
    Date of Event
    January 13, 2021
    Report Date
    January 13, 2021
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    UDI-DI
    10705036003465
    PMA / PMN Number
    K983536
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 03/03/2021. ADDITIONAL INFORMATION RECEIVED: SURGEONS FIRED CDH29A & CDH33A IN A LOW ANTERIOR COLON RESECTION & DID NOT OBTAIN AN AUDIBLE OR TACTILE FEEDBACK OF THE WASHER BREAKING. SURGEON¿S: DR. M & DR. G. (DR. G. FIRED). SURGEON EXPERIENCE WITH THE DEVICE? 5 PLUS YEARS¿ EXPERIENCE OF THE SURGEONS.

    Additional Manufacturer Narrative · 1

    (B)(4). BATCH # UNK. ATTEMPTS HAVE BEEN 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. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FIELD AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A COLON RESECTION THE WASHER DID NOT BREAK BUT THERE WERE TWO COMPLETE DONUTS. SURGEON HAD TO OVER SEW THE ANASTOMOSIS TO COMPLETE THE PROCEDURE WITH NO PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180980 ILS 29MM, CURVED STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. CDH29A U40N6P 10705036003465

    Patients

    Seq Age Sex Outcome Treatment
    1