BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPOUCH RETRIEVER SPEC BAG

    MDR report key: 5211973 · Received November 9, 2015

    Report

    Report Number
    3005075853-2015-07196
    Event Type
    Malfunction
    Date Received
    November 9, 2015
    Date of Event
    October 19, 2015
    Report Date
    October 26, 2015
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GCJ
    PMA / PMN Number
    K011501
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS OF THE POUCH DEVICE FOUND THAT IT WAS RECEIVED FULLY DEPLOYED, BUT OTHERWISE IN GOOD PHYSICAL CONDITION. THE METAL RINGS WERE VISUALLY INSPECTED AND NO ANOMALIES WERE NOTED; THE DEVICE WAS DISASSEMBLED AND THE RINGS WERE PROPERLY ATTACHED TO THE PUSH-PULL ROD. THE SUTURE WAS NOTED TO BE CUT AND IT WAS STILL ATTACHED TO THE DEVICE; BAG WAS NOT RETURNED FOR ANALYSIS. DUE TO THE RETURNED CONDITION OF THE DEVICE, NO FURTHER TESTING COULD BE PERFORMED. AS EACH DEVICE IS VISUALLY INSPECTED AND FUNCTIONALLY TESTED DURING THE MANUFACTURING PROCESS, NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: BATCH # M92A2X . THE ANALYSIS RESULTS OF THE POUCH DEVICE FOUND THAT IT WAS RECEIVED FULLY DEPLOYED. THE SUTURE WAS NOTED TO BE CUT AND IT WAS STILL ATTACHED TO THE DEVICE; BAG WAS NOT RETURNED FOR ANALYSIS. DUE TO THE RETURNED CONDITION OF THE DEVICE, NO FURTHER TESTING COULD BE PERFORMED. AS EACH DEVICE IS VISUALLY INSPECTED AND FUNCTIONALLY TESTED DURING THE MANUFACTURING PROCESS, NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). WHEN ADDITIONAL INFORMATION IS RECEIVED AND/OR THE DEVICE ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SENT. BATCH # UNK. THE LOT HISTORY RECORDS WERE REVIEWED AND THE MANUFACTURING CRITERIA WERE MET PRIOR TO THE RELEASE OF THE LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE SURGEON WAS ATTEMPTING TO RETRIEVE THE SPECIMEN AND HAD DIFFICULTY RETRACTING THE METAL RING. THE DEVICE BROKE IN THE ABDOMEN LEAVING THE SURGEON TO RETRIEVE THE METAL RING. CASE COMPLETED WITH ANOTHER LIKE DEVICE. THERE WAS NO REPORT OF ADVERSE IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    742911 ENDOPOUCH RETRIEVER SPEC BAG LAPAROSCOPE, GENERAL AND PLASTIC SURGERY GCJ ETHICON ENDO-SURGERY, LLC. NA M4J01Y

    Patients

    Seq Age Sex Outcome Treatment
    1