BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC* BLUE HAND PIECE AND BLUE TEST TIP

    MDR report key: 3102927 · Received May 9, 2013

    Report

    Report Number
    3005075853-2013-02202
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 7, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K063192
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION NOT AVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS. SHOULD THE INFORMATION BE PROVIDED LATER, A SUPPLEMENTAL MEDWATCH WILL BE SENT. NO DEVICE RETURNED FOR ANALYSIS, BUT THE HANDPIECE IS A LIMITED LIFE REUSEABLE WHICH WAS MANUFACTURED IN JULY, 2011. THE HANDPIECE MAY BE AND END OF USEFUL LIFE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE O.R. THAT THEY WERE GETTING THE "CHANGE HAND PIECE ERROR" WHEN ATTEMPTING TO USE THEIR HAND PIECES WITH REPROCESSED DEVICES BY ASCENT. THERE WAS NO PATIENT CONSEQUENCE, BUT NO FURTHER INFORMATION CONCERNING EITHER THE PATIENT OR THE CASE. NO DEVICE WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202917 HARMONIC* BLUE HAND PIECE AND BLUE TEST TIP HANDPIECE LFL ETHICON ENDO-SURGERY, LLC. UNK NA

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR