BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELIACATCH

    MDR report key: 7050951 · Received November 21, 2017

    Report

    Report Number
    2936999-2017-05633
    Event Type
    Malfunction
    Date Received
    November 21, 2017
    Date of Event
    November 1, 2017
    Report Date
    November 21, 2017
    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
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: TO DATE, THE INCIDENT SAMPLE HAS NOT BEEN RECEIVED FOR EVALUATION. IF THE SAMPLE IS RECEIVED, OR IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE DEVICE WAS TORN WHILE ATTEMPTING TO REMOVE THE GALLBLADDER FROM THE ABDOMINAL CAVITY. THE ENTIRE BOTTOM OF THE BAG OPENED UP ALONG THE SEAM. THE GALLBLADDER WAS REMOVED WITHOUT A BAG. THERE WAS NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    827764 RELIACATCH LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ CELESTICA ELECTRONICS S PTE LTD CATCH10 C1032317A 10884521704046

    Patients

    Seq Age Sex Outcome Treatment
    1