BEUDAMED
    FDA Adverse Event Other Summary report: N

    ELITE AND USA COLD KNIFE, STRAIGHT BLADE, 3/PKG

    MDR report key: 1948682 · Received December 28, 2010

    Report

    Report Number
    3006159227-2010-00006
    Event Type
    Other
    Date Received
    December 28, 2010
    Date of Event
    November 29, 2010
    Report Date
    December 28, 2010
    Manufacturer
    GYRUS ACMI INC.
    Product Code
    EZO
    PMA / PMN Number
    PREAMEND
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL EXAMINATION OF THE RETURNED PORTION (BLADE ONLY) OF THE K-SB INSTRUMENT FINDS THAT THE BLADE HAS BROKEN CLEANLY FROM THE BASE OF THE INSTRUMENT. THE BLADE EXHIBITS A BREAK PROFILE ON THE RIGHT SIDE OF THE BLADE THAT SUGGESTS SIDE LOADING DURING USE CAUSED THE BLADE TO FRACTURE. THE FRACTURE ORIGINATED ON THE SIDE OF THE BLADE, INDICATING SIDE LOADING. THIS DEVICE IS INTENDED FOR AXIAL CUTTING ONLY. THE INSTRUCTION FOR USE MANUAL WARNS AGAINST SIDE LOADING IN THE WARNINGS SECTION. THE DEVICE FAILED DUE TO ABNORMAL USE BY THE CUSTOMER.

    Description of Event or Problem · 1

    DURING A PROCEDURE, WHILE USING THE ELITE COLD KNIFE STRAIGHT BLADE, THE BLADE BROKE OFF DURING USE IN THE PATIENT'S BLADDER. THE BLADE WAS SUCCESSFULLY RETRIEVED WITHOUT ANY INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELITE AND USA COLD KNIFE, STRAIGHT BLADE, 3/PKG COLD KNIFE, STRAIGHT BLADE, 3/PKG EZO GYRUS ACMI INC. K-SB H883KSB07

    Patients

    Seq Age Sex Outcome Treatment
    1