BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    E-LINE

    MDR report key: 12705292 · Received October 27, 2021

    Report

    Report Number
    9611102-2021-00035
    Event Type
    Malfunction
    Date Received
    October 27, 2021
    Date of Event
    May 2, 2021
    Report Date
    January 4, 2022
    Manufacturer
    RICHARD WOLF GMBH
    Product Code
    FGB
    UDI-DI
    04055207018798
    PMA / PMN Number
    K963855
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW-UP REPORT #1 IS TO PROVIDE FDA WITH MISSING INFORMATION (RESULTS OF THE DEVICE EVALUATION/INVESTIGATION), NEW INFORMATION, AND CHANGED INFORMATION. THE FOLLOWING IS THE RESULTS OF THE DEVICE INVESTIGATION/EVALUATION AS REPORTED BY THE MANUFACTURER: USING PROCESS: ON (B)(6) 2021, FIBROUS URETEROSCOPIC HOLMIUM LASER LITHOTRIPSY WAS PERFORMED. IN THE PROCESS OF LITHOTRIPSY, THE FIBROUS URETEROSCOPE FAILED TO BEND SUDDENLY AND KIDNEY STONES COULD NOT BE FOUND, SO THE OPERATION WAS ABORTED. DETAIL OF THE INVESTIGATION: AFTER CHECKING, THIS SCOPE HAD PROBLEM DURING OPERATION, SO THE OPERATION WAS ABORTED. AFTER THAT, HOSPITAL SENT IT FOR A THIRD PARTY COMPANY FOR REPAIR, NOW IT IS IN NORMAL USE. ANALYSIS OF CAUSE: NORMAL WEAR. INSTRUCTIONS FOR USE: THE HOSPITAL FOUND A THIRD PARTY WHO CARRIED OUT THE REPAIR HIMSELF. THE INSTRUMENT HAS SIGNS OF THIRD-PARTY REPAIR, AS A RESULT OF WHICH IT DOES NOT CORRESPOND TO THE SPECIFICATIONS GIVEN BY RICHARD WOLF GMBH AND IT CAN BE RULED OUT THAT THE INSTRUMENT WAS DELIVERED IN THIS CONDITION. THIS MEANS THAT RICHARD WOLF IS NO LONGER THE MANUFACTURER OF THE PRODUCT. ALL CLAIMS AGAINST RICHARD WOLF ARE EXTINGUISHED BY THE THIRD-PARTY REPAIR. PRODUCT RISK: THE HOSPITAL FOUND A THIRD PARTY WHO CARRIED OUT THE REPAIR HIMSELF. THE INSTRUMENT HAS SIGNS OF THIRD-PARTY REPAIR, AS A RESULT OF WHICH IT DOES NOT CORRESPOND TO THE SPECIFICATIONS GIVEN BY RICHARD WOLF GMBH AND IT CAN BE RULED OUT THAT THE INSTRUMENT WAS DELIVERED IN THIS CONDITION. THIS MEANS THAT RICHARD WOLF IS NO LONGER THE MANUFACTURER OF THE PRODUCT. ALL CLAIMS AGAINST RICHARD WOLF ARE EXTINGUISHED BY THE THIRD-PARTY REPAIR. RICHARD WOLF GMBH CONSIDERS THIS MATTER CLOSED. HOWEVER, IN THE EVENT RWGMBH RECEIVES ANY ADDITIONAL INFORMATION A FOLLOW UP REPORT WILL BE SUBMITTED TO FDA. RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION(RWMIC) SUBMITTING REPORT ON BEHALF OF RWGMBH REPORT.

    Additional Manufacturer Narrative · 0

    (B)(4). THE INSTRUMENT HAS NOT YET BEEN SENT FOR EXAMINATION BY THE USER. AS SOON AS THE EXAMINATION IS COMPLETED, WE WILL SEND A FOLLOW-UP REPORT.

    Description of Event or Problem · 0

    PLEASE SEE MANUFACTURERS NARRATIVE FOR DEVICE EVALUATION/INVESTIGATION RESULTS.

    Description of Event or Problem · 0

    IT WAS REPORTED TO RICHARD WOLF "ON (B)(6) 2021, FIBROUS URETEROSCOPIC HOLMIUM LASER LITHOTRIPSY WAS PERFORMED. IN THE PROCESS OF LITHOTRIPSY, THE FIBROUS URETEROSCOPE FAILED TO BEND SUDDENLY AND KIDNEY STONES COULD NOT BE FOUND, SO THE OPERATION WAS ABORTED. NO INFORMATION IS KNOWN ABOUT THE PATIENT'S STATE OF HEALTH."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1606567 E-LINE URETERORENOSCOPE 12° 8/9.8FR WL 430MM FGB RICHARD WOLF GMBH 8703.534 04055207018798

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown