BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOSCOPE, UTEROSCOPE, VIPER

    MDR report key: 3850793 · Received March 21, 2014

    Report

    Report Number
    1418479-2014-00009
    Event Type
    Malfunction
    Date Received
    March 21, 2014
    Date of Event
    February 1, 2014
    Report Date
    February 20, 2014
    Manufacturer
    RICHARD WOLF MEDICAL INSTRUMENTS CORP.
    Product Code
    FDC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS RETURNED TO THE RICHARD WOLF FACILITY AND INVESTIGATION COMPLETED (B)(4) 2014. UPON VISUAL AND FUNCTIONAL INSPECTION BY THE OPTICS DEPARTMENT, THE ADHESIVE AROUND THE DISTAL HOSE WAS MISSING. THE ROOT CAUSE IS REPROCESSING. ADHESIVE WAS RE-APPLIED AND TESTED PRIOR TO RETURNED TO CUSTOMER. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. IE INTENDED USE, INDICATIONS AND FIELD OF USE, PREPARATION AND CAUTIONS. RWMIC CONSIDERS THIS MATTER CLOSED; HOWEVER, IN THE EVENT ADDITIONAL INFORMATION IS RECEIVED, WE WILL PROVIDE THE FDA WITH FOLLOW-UP INFORMATION.

    Description of Event or Problem · 1

    FACILITY REPORTED THE FLEXIBLE UTEROSCOPE WENT BLURRY DURING CASE; HOWEVER, NO INJURIES WERE REPORTED. A SLIGHT DELAY IN PROCEDURE WAS NOTED, IN ORDER TO SWAP OUT TO BACKUP DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    170356 ENDOSCOPE, UTEROSCOPE, VIPER UTEROSCOPE FDC RICHARD WOLF MEDICAL INSTRUMENTS CORP. 7325.071 606652

    Patients

    Seq Age Sex Outcome Treatment
    1