BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GRIP-TIP URETHRAL SUTURE GUIDE

    MDR report key: 91668 · Received May 16, 1997

    Report

    Report Number
    91668
    Event Type
    Malfunction
    Date Received
    May 16, 1997
    Date of Event
    May 2, 1997
    Report Date
    May 8, 1997
    Manufacturer
    GREENWALD SURGICAL CO., INC.
    Product Code
    FBX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    INSTRUMENT NON-FUNCTIONAL. WHEN CLEANING INSTRUMENT, IT WAS NOT WORKING PROPERLY (UNABLE TO OPEN & CLOSE INSTRUMENT). UPON DISASSEMBLY, INSTRUMENT FOUND FULL OF BLOOD & TISSUE. DISASSEMBLED INSTRUMENT. MFR'S INSTRUCTIONS ARE THAT INSTRUMENT IS NOT TO BE DISASSEMBLED, EVEN FOR CLEANING. MFR'S INSTRUCTIONS FOLLOWED FOR CLEANING & DESPITE FOLLOWING THE INSTRUCTIONS, BLOOD & TISSUE REMAINED. UNABLE TO STERILIZE & CLEAN INSTRUMENT FOLLOWING INSTRUCTIONS FROM CO. NOW HAVE AN INSTRUMENT UNABLE TO USE. THIS INSTRUMENT WAS USED ON AT LEAST 17 PTS. HOSP ATTEMPTING TO LEARN OF ANY ILL EFFECTS/INFECTIONS PTS MIGHT HAVE SUSTAINED AS A RESULT OF THIS INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GRIP-TIP URETHRAL SUTURE GUIDE GREENWALD PROSTATE SOUND FBX GREENWALD SURGICAL CO., INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *