BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    "E-LINE" URETERORENOSCOPE

    MDR report key: 9951015 · Received April 10, 2020

    Report

    Report Number
    9611102-2020-00003
    Event Type
    Malfunction
    Date Received
    April 10, 2020
    Date of Event
    November 25, 2019
    Report Date
    July 14, 2020
    Manufacturer
    RICHARD WOLF GMBH
    Product Code
    FGB
    UDI-DI
    04055207020036
    PMA / PMN Number
    K062720
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION (RWMIC) IS SUBMITTING THE REPORT ON BEHALF OF RW GMBH. THE FOLLOWING FIELDS CONTAIN NEW/CHANGE INFORMATION : B4, B5, D10, G7, H1, H2, H3, H6 AND H10. THE SCOPE WAS REPLACED WITH ANOTHER THAT WAS READY IN THE OPERATING ROOM. THE SCOPE WAS DAMAGED BY THE USER BY FIRING THE LASER. THIS IS A USER ERROR THAT DID NOT CAUSE ANY ADVERSE EFFECTS AND CAN BE REPAIRED UNDER NORMAL REPAIR PROCEDURES. THERE WAS NO HARM TO THE PATIENT, NO SIGNIFICANT DELAY IN PROCEDURE AND THE OPERATION COULD BE COMPLETED SUCCESSFULLY. 1X 8703534 URETERORENOSKOP 12° 8/9,8CH NL 430MM WITH THE SERIAL NUMBER (B)(6) 3 WAS MANUFACTURED ON 04.10.2018. IT WAS DELIVERED TO THE CUSTOMER 210497 ON 30.10.2018. THE INSTRUCTIONS FOR USE GA-D 352 CONTAINS A CAUTION TO ENSURE THAT PRODUCTS MUST NOT BE COMBINED INCORRECTLY: CAUTIONS DO NOT COMBINE PRODUCTS INCORRECTLY! INJURIES OF THE PATIENT, USER OR OTHERS AS WELL AS DAMAGE TO THE PRODUCT IS POSSIBLE. THE DIFFERENT PRODUCTS CAN ONLY BE USED TOGETHER IF THEIR INTENDED USES AND RELEVANT TECHNICAL DATA (SUCH AS WORKING LENGTH, DIAMETER, PEAK VOLTAGE, ETC.) ARE THE SAME. FOLLOW THE INSTRUCTION MANUAL OF THE PRODUCTS USED IN COMBINATION WITH THIS PRODUCT. FOLLOW THE "NOTES AND INSTRUCTIONS ON HF APPLICATIONS", ORDER NO.: GA-S 002 AS WELL AS THE HF DEVICE MANUFACTURER'S INSTRUCTIONS. 7.4.3 ADDITIONAL NOTES AND INSTRUCTIONS ON LASER LITHOTRIPSY WHEN APPLYING A LASER MAKE SURE YOU FOLLOW THE LASER DEVICE MANUFACTURER'S INSTRUCTIONS AS WELL AS THE GENERAL REGULATIONS ON THE USE OF LASERS. WEAR THE REQUIRED PERSONAL PROTECTION EQUIPMENT. 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 ARE POSSIBLE. ACTIVATE THE LASER ONLY AFTER THE TIP OF THE LASER FIBER HAS BECOME FULLY VISIBLE THROUGH THE ENDOSCOPE AND CONTACT IS MADE WITH THE PLANNED APPLICATION AREA. CAUTION! HIGH TEMPERATURES DUE TO HIGHLY COHERENT LASER BEAM! THE HEAT GENERATED BY THE LASER BEAM REDUCES THE STRENGTH OF INSTRUMENT PARTS. DO NOT DIRECT THE LASER BEAM AT INSTRUMENT PARTS, IN PARTICULAR NOT AT PLASTIC PARTS. KEEP A SAFE DISTANCE. AS THE CUSTOMER CHOSE THIRD PARTY REPAIRERS TO REPAIR THE DEVICE, RICHARD WOLF CAN NO LONGER GUARANTEE THE PERFORMANCE OR THE INTEGRITY OF REPAIRS CARRIED OUT BY UNAUTHORIZED REPAIRERS. POSSIBLE HAZARDS WERE CONSIDERED IN THE RISK ASSESSMENT A1 REV. 05 WITH THE CORRESPONDING EXTENT OF DAMAGE AND PROBABILITY OF OCCURRENCE AND ASSESSED WITH AN ACCEPTABLE RISK. THIS ASSESSMENT IS STILL VALID EVEN TAKING INTO ACCOUNT THE CURRENT CASE. AS THIS WAS A CLEAR USER ERROR, THERE WAS NO PRODUCT- OR PRODUCTION-RELATED FAILURE, NO ADVERSE EFFECTS ON PATIENTS, USERS, OR THIRD PARTIES, THERE IS NO SYSTEMIC ISSUE RELATED TO THE PRODUCT OR ITS MANUFACTURE AND THE INSTRUCTIONS FOR USE CONTAIN ADEQUATE WARNINGS AND CAUTIONS RELATED TO THE REPORTED ISSUE IN THIS CASE, NO FURTHER INVESTIGATION OR ACTION IS WARRANTED. RICHARD WOLF GMBH (RWGMBH) CONSIDERS THIS MATTER CLOSED. HOWEVER, IN THE EVENT RWGMBH RECEIVES ANY 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

    THE INVESTIGATION IS ON-GOING. A FOLLOW UP WILL BE SUBMITTED UPON RECEIPT OF ADDITIONAL INFORMATION. (B)(4) CONSIDERS THIS CASE OPEN.

    Description of Event or Problem · 1

    ON (B)(6) 2020, (B)(4) RECEIVED THE FOLLOWING INFORMATION: AT 9:00 O 'CLOCK ON (B)(6) 2019, THE UROLOGIST PERFORMED THE OPERATION WITH FIBER-URETEROSCOPY, AND FOUND THAT ALL THE IMAGES COULD NOT BE SHOWN, SO HE STOPPED THE DEVICE AND REPORTED TO THE EQUIPMENT DEPARTMENT FOR REPAIR IMMEDIATELY, WHICH DELAYED THE TREATMENT OF THE PATIENT. THE OPERATION WAS CONTINUED WITH A REPLACEMENT DEVICE THAT WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412018 "E-LINE" URETERORENOSCOPE URETERORENOSCOPE FGB RICHARD WOLF GMBH 8703.534 04055207020036

    Patients

    Seq Age Sex Outcome Treatment
    1 Other