BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO CATCH GOLD

    MDR report key: 7589315 · Received June 11, 2018

    Report

    Report Number
    9612501-2018-01091
    Event Type
    Injury
    Date Received
    June 11, 2018
    Date of Event
    May 24, 2018
    Report Date
    October 3, 2018
    Manufacturer
    DAVIS & GECK CARIBE LTD
    Product Code
    GCI
    UDI-DI
    10884523000955
    PMA / PMN Number
    K922123
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    K922123. 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. DISTAL END OF POUCH WAS STRETCHED, DEFORMED AND TORN BEFORE THE WELD. 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 SPECIMEN RETRIEVAL PROCESS THE SPECIMEN POUCH IS SUBJECTED TO EXCESSIVE MANIPULATION OR FORCES WHICH CAUSES STRETCHING AND DEFORMATION TO THE SPECIMEN POUCH UNTIL IT ULTIMATELY RIPS. THE ROOT CAUSE OF THE OBSERVED DAMAGE WAS MISUSE OF THE PRODUCT WHICH WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. 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 ROBOTIC SURGERY WITH DA VINCI FOR PROSTATE CANCER, WHEN THE SURGEON TRIED TO REMOVE A SPECIMEN WITH THE DEVICE, THE POUCH WAS FOUND TO BE BROKEN AT THE BOTTOM, EVEN THOUGH THE SPECIMEN WAS APPROPRIATE SIZE FOR THE POUCH. THE SURGERY HAD BEEN PLANNED TO BE DONE COMPLETELY LAPAROSCOPICALLY, BUT A SMALL INCISION WAS NEEDED TO CHECK THE ABDOMINAL CAVITY. THEY RETRIEVED THE BROKEN PIECES FROM THE CAVITY AND ALSO FROM ON THE PATIENT'S BACK. THE INCISION SITE WAS EXTENDED BY MORE THAN 3 CM. THE SURGICAL TIME WAS EXTENDED BY LESS THAN 30 MINUTES. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429885 ENDO CATCH GOLD LARYNGOSCOPE, ENDOSCOPE GCI DAVIS & GECK CARIBE LTD 173050G J8A2157MX 10884523000955

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R