BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION HARMONIC SCALPEL CURVED SHEARS (LCS) - PISTOL GRIP 36 CM - 15 MM ACT

    MDR report key: 1081891 · Received July 22, 2008

    Report

    Report Number
    3005075853-2008-00619
    Event Type
    Malfunction
    Date Received
    July 22, 2008
    Date of Event
    June 2, 2008
    Report Date
    June 25, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    GEI
    PMA / PMN Number
    K002981
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 7/22/08. INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC SIGMOIDECTOMY PROCEDURE, THE ACTIVE BLADE BROKE. UNK HOW THE CASE WAS COMPLETED. THERE WAS NO PT CONSEQUENCE. NO FURTHER INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRACISION HARMONIC SCALPEL CURVED SHEARS (LCS) - PISTOL GRIP 36 CM - 15 MM ACT GEI ETHICON ENDO-SURGERY, LLC NA E34K66D

    Patients

    Seq Age Sex Outcome Treatment
    1 HANDPIECE| GENERATOR