BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPOUCH SPEC BAG

    MDR report key: 2050227 · Received April 12, 2011

    Report

    Report Number
    3005075853-2011-01453
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    March 2, 2011
    Report Date
    March 16, 2011
    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
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS OF THE DEVICE FOUND THAT IT WAS RECEIVED WITH THE PUSH PULL ROD BROKEN MAKING THE INSTRUMENT NON-FUNCTIONAL. A POSSIBLE CAUSE OF THIS CONDITION MAY BE THAT AN INCORRECT BENDING OR TORSION WAS APPLIED TO THE DEVICE DURING THE DEPLOYMENT OR CINCHING CAUSING THE BREAKING OF THE PUSH PULL ROD. IN ADDITION, THE SUTURE WAS NOTED TO BE BROKEN. PLEASE NOTE THAT THIS CONDITION IS UNRELATED WITH THE INCIDENT REPORTED. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPOUCH SPEC BAG LAPAROSCOPE, GENERAL AND PLASTIC SURGERY GCJ ETHICON ENDO-SURGERY, LLC. NA G4TA08

    Patients

    Seq Age Sex Outcome Treatment
    1