BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELIACATCH

    MDR report key: 11869653 · Received May 24, 2021

    Report

    Report Number
    2936999-2021-00471
    Event Type
    Malfunction
    Date Received
    May 24, 2021
    Date of Event
    March 31, 2021
    Report Date
    May 24, 2021
    Manufacturer
    CELESTICA ELECTRONICS S PTE LTD
    Product Code
    GCJ
    UDI-DI
    10884521704046
    PMA / PMN Number
    K163102
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, ON A LAPAROSCOPIC CHOLECYSTECTOMY, DURING SPECIMEN REMOVAL, THE BAG TORE. THE SPECIMEN WAS REMOVED WITH THE RIPPED BAG. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    765416 RELIACATCH LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ CELESTICA ELECTRONICS S PTE LTD CATCH10 C1062420A 10884521704046

    Patients

    Seq Age Sex Outcome Treatment
    1