BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELIACATCH

    MDR report key: 6954892 · Received October 17, 2017

    Report

    Report Number
    2936999-2017-05564
    Event Type
    Malfunction
    Date Received
    October 17, 2017
    Date of Event
    September 27, 2017
    Report Date
    April 20, 2018
    Manufacturer
    CELESTICA ELECTRONICS S PTE LTD
    Product Code
    GCJ
    PMA / PMN Number
    K163102
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION: (FIRST NAME, LAST NAME, EMAIL), (PHONE NUMBER). (EVALUATION SUMMARY): EVALUATION SUMMARY POST MARKET VIGILANCE OBSERVED ONE PHOTOGRAPH OF THE DEVICE OPENED WITH THE APPROPRIATE PACKAGING IN AN UNDAMAGED CONDITION. THE PHOTO WAS RETURNED IN PLACE OF THE DEVICE AND THROUGH OBSERVATION IT APPEARS THAT THE DEVICE BAG TORE AT THE NECK, AT THE POINT OF TRANSITION TO THE TAIL. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    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, DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE BAG OF THE DEVICE TORE WHILE BEING USED AT THE END OF REMOVING THE GALL BLADDER. NO SPECIMEN FELL INTO PATIENT¿S CAVITY. A FORCEPS WAS USED TO GET THE BAG OUT OF PATIENT. THERE WAS NO INJURY CAUSED TO THE PATIENT AND NO MEDICAL INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    735068 RELIACATCH LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ CELESTICA ELECTRONICS S PTE LTD CATCH10 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1