BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE 36CM W ERG HANDLE

    MDR report key: 1933726 · Received December 21, 2010

    Report

    Report Number
    3005075853-2010-07283
    Event Type
    Malfunction
    Date Received
    December 21, 2010
    Date of Event
    December 9, 2010
    Report Date
    December 9, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K042777
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). ADDED ADDITIONAL INFORMATION: THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RETURNED WITH THE TISSUE PAD MISSING. THE DEVICE WAS TESTED WITH A TEST HANDPIECE AND GENERATOR AND THE DEVICE DID ACTIVATE. AS THE TISSUE PAD IS NO LONGER ATTACHED TO THE CLAMP ARM, FURTHER FUNCTIONALLY TESTING COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC SIGMOIDECTOMY PROCEDURE, THE TISSUE PAD FELL OFF INTO THE PATIENT. THEY CONTINUED TO USE THE DEVICE FOR A COUPLE OF MINUTES AFTER THE TISSUE PAD HAD FALLEN OFF. IT IS UNKNOWN IF THE TISSUE PAD WAS RETRIEVED. A CIRCULAR STAPLER WAS USED TO COMPLETE THE ANASTOMOSIS. THEY IRRIGATED AND CLOSED THE PATIENT. THE PATIENT IS CURRENTLY OKAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC ACE 36CM W ERG HANDLE INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR AND HANDPIECE