BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELIACATCH

    MDR report key: 7084342 · Received December 5, 2017

    Report

    Report Number
    2936999-2017-05652
    Event Type
    Malfunction
    Date Received
    December 5, 2017
    Date of Event
    November 6, 2017
    Report Date
    April 11, 2018
    Manufacturer
    CELESTICA ELECTRONICS S PTE LTD
    Product Code
    GCJ
    PMA / PMN Number
    K163102
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF ONE DEVICE. DEVICE WAS RETURNED WITH OUTER TUBE AND TUBE HOUSING SEPARATED FROM THE REST OF THE DEVICE (UNSHEATHED). OUTER TUBE WAS STILL IN TROCAR WITH SPECIMEN BAG TAIL TRAVERSING OUTER TUBE. SPECIMEN BAG WAS RIPPED IN AREA WHERE METAL RING ENTERS SPECIMEN BAG. SPECIMEN BAG WAS COMPLETELY CINCHED. ENGINEERING FOUND THAT 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 THE TAIL TAB IS PREMATURELY REMOVED, FOLLOWED BY THE FORK HANDLE BEING PULLED OUT OF THE DEVICE/TUBE AND THEN REDEPLOYMENT OF THE FORK IS ATTEMPTED RESULTING IN DAMAGE TO THE SPECIMEN POUCH. THE ROOT CAUSE OF THE OBSERVED DAMAGE WAS MISUSE OF THE PRODUCT WHICH WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. 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.

    Additional Manufacturer Narrative · 1

    CORRECTION: (UDI). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    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.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: OCCURRED DURING A LAPAROSCOPIC WEDGE RESECTION PROCEDURE. WHEN THE SPECIMEN BAG WAS REMOVED FROM THE PATIENT, THE BAG HAD RIPPED AT THE METAL RING. THE METAL RING WAS NOT REMOVED AND CAUSED THE TOP PART OF THE BAG TO RIP. IN ORDER TO RESOLVE THE ISSUE AND COMPLETE THE CASE, THE SURGEON WAS ABLE TO USE A CLAMP TO REMOVE THE REMAINING BAG WITH THE SPECIMEN INTACT. THERE WAS NO PATIENT HARM. THE PATIENT OUTCOME IS ALIVE, NO INJURY.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: OCCURRED DURING A LAPAROSCOPIC WEDGE RESECTION PROCEDURE. WHEN THE SPECIMEN BAG WAS REMOVED FROM THE PATIENT, THE BAG HAD RIPPED AT THE METAL RING. THE METAL RING WAS NOT REMOVED AND CAUSED THE TOP PART OF THE BAG TO RIP. IN ORDER TO RESOLVE THE ISSUE AND COMPLETE THE CASE, THE SURGEON WAS ABLE TO USE A CLAMP TO REMOVE THE REMAINING BAG WITH THE SPECIMEN INTACT. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    861876 RELIACATCH LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ CELESTICA ELECTRONICS S PTE LTD CATCH10

    Patients

    Seq Age Sex Outcome Treatment
    1