BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE 36CM W ERG HANDLE

    MDR report key: 1160573 · Received September 11, 2008

    Report

    Report Number
    3005075853-2008-01644
    Event Type
    Malfunction
    Date Received
    September 11, 2008
    Date of Event
    August 18, 2008
    Report Date
    August 19, 2008
    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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT RETURNED FOR EVALUATION. THE COMPLAINT COULD NOT BE CONFIRMED, BECAUSE NO DEVICE WAS RETURNED FOR ANALYSIS. WE DID NOT RECEIVE A BATCH OR LOT NUMBER FOR THE PRODUCT INVOLVED IN THIS COMPLAINT. THEREFORE, WE WERE UNABLE TO CHECK MANUFACTURING RECORDS FOR ANY RELATED NON-CONFORMANCES. COMPLAINT INFORMATION IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SALES REP THAT DURING A LAP NISSEN, THE TISSUE PAD FELL OFF. UNSURE IF ANY OF THE TISSUE PAD FELL INTO THE PATIENT. USED ANOTHER LIKE DEVICE TO COMPLETE THE CASE WITHOUT ANY PATIENT CONSEQUENCE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 HANDPIECE| GENERATOR