BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENSEAL 5MM ROUND TIP 35 CM

    MDR report key: 1914216 · Received December 3, 2010

    Report

    Report Number
    3005075853-2010-06854
    Event Type
    Malfunction
    Date Received
    December 3, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 15, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GEI
    PMA / PMN Number
    K072177
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED WITH A STAPLE BETWEEN THE JAWS. TESTING FOUND A SHORT ON THE DEVICE WHEN THE JAWS WERE CLOSED, CAUSING A REPLACE LIGHT TO ILLUMINATE. THE STAPLE EMBEDDED ON THE ELECTRODE CREATED ELECTRODE TO JAW CONTACT WHICH CAUSED AN ELECTRICAL SHORT AND THE REPLACE DEVICE WARNING TO ILLUMINATE PREVENTING RF POWER DELIVERY FROM THE GENERATOR. THIS COULD HAVE AFFECTED THE SEALING PERFORMANCE OF THE DEVICE.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL ANALYSIS PERFORMED. ADDITIONAL ANALYSIS PERFORMED: THE DEVICE WAS RECEIVED WITH A STAPLE BETWEEN THE JAWS. TESTING FOUND A SHORT ON THE DEVICE WHEN THE JAWS WERE CLOSED, CAUSING A REPLACE LIGHT TO ILLUMINATE. THE STAPLE WAS REMOVED FROM THE JAWS AND THE DEVICE WORKED AS INTENDED. THEREFORE, THE STAPLE EMBEDDED ON THE ELECTRODE CREATED ELECTRODE TO JAW ELECTRICAL SHORT AND RESULTED IN THE REPLACE DEVICE WARNING TO ILLUMINATE, PREVENTING RF POWER DELIVERY FROM THE GENERATOR. THIS COULD HAVE AFFECTED THE SEALING PERFORMANCE OF THE DEVICE.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC DISTAL PANCREATECTOMY PROCEDURE THE SURGEON TRIED TO STOP THE BLEEDING ON THE STAPLE LINE WITH THE DEVICE AND HIT A STAPLE. THE DEVICE YELLOW REPLACE LIGHT DID NOT ILLUMINATE NOR DID IT SEAL PROPERLY AT THAT TIME. THE DEVICE WOULD TIME OUT AFTER 25 SECONDS. THE SURGEON PLACED CLIPS ON THE STAPLE LINE AND THEN CONTINUED WITH A NEW DEVICE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE REPORTED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENSEAL 5MM ROUND TIP 35 CM ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ETHICON ENDO-SURGERY, LLC. UNK G4TR61

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR AND HANDPIECE