BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERIS PADLOCK CLIP CLOSURE

    MDR report key: 14358930 · Received May 10, 2022

    Report

    Report Number
    MW5109628
    Event Type
    Malfunction
    Date Received
    May 10, 2022
    Date of Event
    March 27, 2022
    Report Date
    March 27, 2022
    Manufacturer
    UNITED STATES ENDOSCOPY GROUP, INC. / US ENDOSCOPY
    Product Code
    PKL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    STERIS PADLOCK CLIP FAILED TO DEPLOY WHILE DOING PROCEDURE BY DR (B)(6). THE VENDOR WAS ALERTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    872043 STERIS PADLOCK CLIP CLOSURE HEMOSTATIC METAL CLIP FOR THE GI TRACT PKL UNITED STATES ENDOSCOPY GROUP, INC. / US ENDOSCOPY C910001 2006622

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Male