BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    24FR 90? CUTTING LOOP ELECTRODE, .014 (6BX)

    MDR report key: 1113322 · Received August 12, 2008

    Report

    Report Number
    2936485-2008-00067
    Event Type
    Malfunction
    Date Received
    August 12, 2008
    Date of Event
    April 24, 2008
    Report Date
    July 11, 2008
    Manufacturer
    STRYKER ENDOSCOPY SAN JOSE
    Product Code
    KNS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE PROVIDED ONCE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SURGERY ON THIS DATE FOR TURP AND REMOVAL OF BLADDER STONES FOR URINARY RETENTION, IT WAS NOTED THAT THE IGLESIAS LOOP HAD BROKEN SUCH THAT ONLY THE TWO PRONGS WERE VISIBLE OUTSIDE OF THE SCOPE. A PIECE OF THE LOOP WAS NOTED TO BE ON THE BLADDER FLOOR AND REMOVED INTACT. REVIEW REVEALED THAT NO INJURY OCCURRED TO THE PATIENT FROM THE BROKEN DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 24FR 90? CUTTING LOOP ELECTRODE, .014 (6BX) ELECTRODE KNS STRYKER ENDOSCOPY SAN JOSE NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK