BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELIACATCH

    MDR report key: 6934212 · Received October 10, 2017

    Report

    Report Number
    2936999-2017-05545
    Event Type
    Malfunction
    Date Received
    October 10, 2017
    Date of Event
    August 31, 2017
    Report Date
    January 5, 2018
    Manufacturer
    CELESTICA ELECTRONICS S PTE LTD
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF ONE DEVICE. ONLY THE SPECIMEN BAG WITH ATTACHED CORD WAS RETURNED. PMV OBSERVED THAT WAS BAG WAS PARTIALLY CINCHED, TORN NEAR THE CINCHING POINT AND COMPLETELY TORN THROUGH AT THE DISTAL END. NH R&D FOUND THAT THE RIP NEAR THE TAIL OF THE BAG WAS INDICATIVE OF THE USE OF EXCESSIVE FORCE IN REMOVING THE BAG FROM THE PATIENT CAVITY. NH R&D ALSO FOUND THROUGH DISCUSSION THAT THE BAG WAS PURPOSELY EXPOSED TO EXCESSIVE FORCE POST PROCEDURE WHICH CONTRIBUTED TO THE CONDITION THE BAG WAS RECEIVED IN. RECORDS FROM EACH MANUFACTURING LOT ARE THOROUGHLY REVIEWED TO ENSURE THAT PRODUCTS ARE RELEASED MEETING ALL QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE. REPLICATION OF THE OBSERVED CONDITION MAY OCCUR IF DURING REMOVAL OF THE SPECIMEN RETRIEVAL BAG THE INCISION IS NOT LARGE ENOUGH TO ALLOW EASY PASSAGE OF THE BAG; THIS NECESSITATES THE USE OF EXCESSIVE FORCE AND SUBSEQUENTLY CREATES A RIP IN THE BAG UNDER TENSION. SHOULD NEW INFORMATION BECOME AVAILABLE, THE FILE WILL BE RE-OPENED AND THE INVESTIGATION SUMMARY WILL BE AMENDED AS APPROPRIATE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, WHILE THE SURGEON WAS REMOVING SPECIMEN THROUGH TROCAR SITE DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE BAG WAS RIPPED WHEN PULLING ON TAIL (NEAR WHERE IT ATTACHES TO THE BAG) WHILE TRYING TO GET THE BAG OUT OF PATIENT. ONCE REMOVED, THE SCRUB TECHNICIAN DECIDED TO TEST THE STRENGTH OF THE BAG ONCE IT CONTAINED GASTRIC JUICES, AND IT RIPPED VERY EASILY. THE INCISION WAS EXTENDED 2.54CM DUE TO THE PRODUCT PROBLEM. THE CASE WAS COMPLETED WITH THE CURRENT PRODUCT. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    718058 RELIACATCH LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ CELESTICA ELECTRONICS S PTE LTD CATCH10 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1