BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HS ACE 23 CM SCISSOR HANDLE

    MDR report key: 1810008 · Received November 12, 2007

    Report

    Report Number
    1527736-2007-07562
    Event Type
    Malfunction
    Date Received
    November 12, 2007
    Date of Event
    October 17, 2007
    Report Date
    October 31, 2007
    Manufacturer
    ETHICON ENDO SURGERY, INC (CINCINNATI)
    Product Code
    LFL
    PMA / PMN Number
    K051036
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ANTERIOR COLONIC RESECTION PROCEDURE, THE DOCTOR SAID THAT THE SHEAR APPEARED TO DECREASE IN EFFICACY ON MINIMUM POWER LEVEL, AND WORKED GENERALLY BELOW THE ACCEPTABLE LEVEL ON MAXIMUM POWER LEVEL. COMPLETED WITH THE SAME LIKE PRODUCT. THERE WAS NO PT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HS ACE 23 CM SCISSOR HANDLE LFL ETHICON ENDO SURGERY, INC (CINCINNATI) NA C4G07R

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR| HANDPIECE