BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 1172487 · Received September 22, 2008

    Report

    Report Number
    3005075853-2008-01858
    Event Type
    Malfunction
    Date Received
    September 22, 2008
    Report Date
    August 29, 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
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A COLON PROCEDURE, THE ACTIVE BLADE BROKE OFF. THE BROKEN PART WAS NEVER FOUND. NO PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRACISION HARMONIC SCALPEL CURVED SHEARS (LCS)-PISTOL GRIP 36CM-15MM ACTIVE BL GEI ETHICON ENDO-SURGERY, LLC NA C4FT5M

    Patients

    Seq Age Sex Outcome Treatment
    1 HANDPIECE| GENERATOR