BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEPHROSCOPE 20° 24FR. WL 224MM RIGID WITH LATERAL OCULAR LENS WORKING CHANNEL

    MDR report key: 7550175 · Received May 29, 2018

    Report

    Report Number
    9611102-2018-00010
    Event Type
    Malfunction
    Date Received
    May 29, 2018
    Date of Event
    April 17, 2018
    Report Date
    May 29, 2018
    Manufacturer
    RICHARD WOLF GMBH
    Product Code
    FGA
    UDI-DI
    04055207023327
    PMA / PMN Number
    K994223
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    YM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). TO OBTAIN OPTIMUM LIGHT TRANSMISSION, THE DIAMETERS OF THE FIBRE BUNDLE OF THE ENDOSCOPE AND OF THE FIBRE LIGHT CABLE MUST BE THE SAME. POSSIBLE CAUSES WHEN USING A FIBRE LIGHT CABLE THAT IS TOO SMALL: THE LIGHT OUTPUT IS REDUCED. CAUTION! INCREASED DANGER POTENTIAL IF IMAGE IS BLURRED! PATIENT MAY BE INJURED. STOP OPERATION FOR SAFETY REASONS IF IMAGE IS BLURRED. CHECK IMAGE QUALITY OF ENDOSCOPE BEFORE USE. CAUTION! DO NOT WORK OUTSIDE THE SCOPE'S FIELD OF VIEW! INADVERTENT TISSUE DAMAGE AS WELL AS DAMAGE TO THE DISTAL END OF THE ENDOSCOPE AND INSTRUMENT PARTS CAN OCCUR. CHECK IMAGE QUALITY AND LIGHT OUTPUT IN CONJUNCTION WITH THE SYSTEM COMPONENTS. AN INVESTIGATION WAS UNABLE TO BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. MULTIPLE ATTEMPTS WERE MADE TO CONTACT THE USER FACILITY, BUT NO RESPONSE WAS PROVIDED. RICHARD WOLF GMBH (RWGMBH) CONSIDERS THIS MATTER CLOSED. IN THE EVENT RWGMBH RECEIVES ADDITIONAL INFORMATION A FOLLOW UP REPORT WILL BE SUBMITTED TO FDA.

    Description of Event or Problem · 0

    FOLLOW UP REPORT TO PROVIDE ADDITIONAL INFORMATION TO FDA.

    Additional Manufacturer Narrative · 1

    INVESTIGATION / EVALUATION CURRENTLY IN PROCESS. RW (B)(4) CONSIDERS THIS REPORT OPEN, FOLLOW-UP REPORT TO BE SUBMITTED ONCE INVESTIGATION IS COMPLETE. RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION (RWMIC) IS SUBMITTING THIS REPORT ON BEHALF OF RICHARD WOLF (B)(4). RW (B)(4) IS MANUFACTURER.

    Description of Event or Problem · 1

    AT THE FIRST TEN MINUTES OF THE OPERATION THE NEPHROSCOPE 8965.411 WAS EXCELLENT AND THEN WE STARTED THE SECOND OPERATION AND VISION BEGAN TO DISAPPEAR GRADUALLY THE SAME DAY. UNFORTUNATELY THE OPERATION WAS NOT COMPLETED. MANUFACTURED DATE: 08 MARCH 2018. LOT SIZE: (B)(4) UNITS. PURCHASE DATE: (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393390 NEPHROSCOPE 20° 24FR. WL 224MM RIGID WITH LATERAL OCULAR LENS WORKING CHANNEL NEPHROSCOPE 20° 24FR WL224MM FGA RICHARD WOLF GMBH 8965.411 04055207023327

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Other