BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    E-LINE URETERORENOSKOP 12 8/9,8CH NL 430MMH

    MDR report key: 10276316 · Received July 15, 2020

    Report

    Report Number
    9611102-2020-00014
    Event Type
    Malfunction
    Date Received
    July 15, 2020
    Date of Event
    June 16, 2020
    Report Date
    July 19, 2020
    Manufacturer
    RICHARD WOLF GMBH
    Product Code
    FGB
    UDI-DI
    04055207020081
    PMA / PMN Number
    K963855
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE URETERORENOSCOPE 12° 8/9,8CH NL 430MM WAS EXAMINED BY RICHARD WOLF. DURING THE VISUAL EXAMINATION IT WAS FOUND THAT THE SHEATHING TUBE DISTALLY APPROX. 10 CM FROM THE DISTAL END IS STRONGLY BENT, SQUEEZED AND TORN. THIS DAMAGE CAN ONLY BE CAUSED MECHANICALLY. THE CAUSE OF THE DEFECT WAS CLASSIFIED AS MECHANICAL OVERLOAD. THE CONCLUSION OF THE INVESTIGATION IS THAT THIS DAMAGE COULD ONLY BE CAUSED MECHANICALLY. THE CAUSE OF THE FAULT WAS CLASSIFIED AS MECHANICAL OVERLOAD. THE INSTRUMENT MUST HAVE BEEN BENT AGAINST A HARD EDGE. HOW THIS COULD HAPPEN DURING THE INTENDED USE OF THE PRODUCT ON THE PATIENT IS NOT COMPREHENSIBLE. IN ADDITION, NO DAMAGE OR INJURY TO THE PATIENT HAS BEEN REPORTED. THE URETERORENOCOPE WAS MANUFACTURED WITH PRODUCTION ORDER (B)(4). THE PRODUCTION ORDER CONSISTS OF A TOTAL OF 10 UNITS. THE EXAMINATION OF THE PRODUCTION DOCUMENTS SHOWS NO DEVIATIONS OR ABNORMALITIES. 1X 8703524 URETERORENOSCOPE 12° 8/9,8CH NL 430MM WITH SERIAL NUMBER (B)(4) FROM BATCH 1440225. THE URETERORENOSCOPE WAS MANUFACTURED WITH PRODUCTION ORDER (B)(4) ON (B)(6) 2020. THE PRODUCTION ORDER CONSISTS OF 10 PIECES IN TOTAL. THE URETERORENOSCOPE WITH DELIVERY NOTE 81709377 WAS DELIVERED TO THE CUSTOMER ON (B)(6) 2020. ACCORDING TO SAP, REPAIRS TO THE URETERORENOSCOPE HAVE NOT YET BEEN CARRIED OUT. GA GA-D 352 / EN / 2018-12 V6.0 / PK18-9377 CONTAINS THE FOLLOWING APPLICABLE WARNINGS FOR THESE ERRORS: 7 APPLICATION CAREFUL! LIMITED STABILITY OF THE PRODUCTS! EXCESSIVE FORCE APPLICATIONS LEAD TO DAMAGE, IMPAIR THE FUNCTION AND THUS ENDANGER THE PATIENT. PRODUCTS IMMEDIATELY BEFORE AND AFTER USE FOR DAMAGE, LOOSE CHECK PARTS AND COMPLETENESS. NO MISSING PARTS MAY REMAIN IN THE PATIENT. PRODUCTS THAT ARE DAMAGED, INCOMPLETE OR HAVE LOOSE PARTS MUST NOT USE MORE. 8 CONTROL CAREFUL! CAUTION WITH DAMAGED AND INCOMPLETE PRODUCTS! INJURIES TO THE PATIENT, USER AND THIRD PARTIES ARE POSSIBLE. PERFORM CHECKS BEFORE AND AFTER EACH APPLICATION. DO NOT USE PRODUCTS THAT ARE DAMAGED, INCOMPLETE OR HAVE LOOSE PARTS. USE MORE. SEND DAMAGED PRODUCTS WITH THE LOOSE PARTS FOR REPAIR. DO NOT ATTEMPT TO REPAIR YOURSELF. 8.1 VISUAL INSPECTION CHECK INSTRUMENTS, ESPECIALLY IN THE DISTAL AREA, AND ACCESSORIES FOR DAMAGE TO THE INSTRUMENT TIP (4) TO PREVENT URETERAL TRAUMA. SURFACE CHANGES (E.G. CORROSION), SHARP RIMS.LOOSE OR MISSING PARTS, ROUGH SURFACES. ALL INSCRIPTIONS AND MARKINGS REQUIRED FOR SAFE AND PROPER USE MUST BE LEGIBLE. MISSING, ILLEGIBLE INSCRIPTIONS AND MARKINGS WHICH LEAD TO ERRORS IN HANDLING AND PROCESSING MUST BE RESTORED. POSSIBLE HAZARDS WERE CONSIDERED IN THE RISK ASSESSMENT A1 REV.05 WITH THE CORRESPONDING EXTENT OF DAMAGE AND PROBABILITY OF OCCURRENCE. BASED ON A REVIEW OF THE COMPLAINT DATABASE, NO TRENDS OR SYSTEMIC PROBLEMS RELATED TO A PRODUCT PROBLEM ARE INDICATED. THERE IS A SIMILAR CASE SO FAR WHERE THE SHEATH OF THE 8703534 URETERORENOSCOPE HAS BEEN REPORTED TO BE BENT DURING USE. IN BOTH CASES THERE WAS NO PRODUCT OR PRODUCTION RELATED ROOT CAUSE. THE INVESTIGATION IN BOTH CASES SHOWED THAT THE DAMAGE CAUSED TO THE PRODUCT WAS DUE TO MECHANICAL OVERLOAD. CONSEQUENTLY, NO FURTHER ACTION IS CURRENTLY BEING TAKEN WITH RESPECT TO THIS INCIDENT OTHER THAN MONITORING OTHER CASES TO DETERMINE A POSSIBLE TREND. 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. RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION (RWMIC) IS SUBMITTING THE REPORT ON BEHALF OF RWGMBH.

    Description of Event or Problem · 1

    AT THE REMOVAL OF THE URETERAL STONE ON (B)(6) 2020, THE 8703524 URETERORENOSCOPE 12° 8/9,8CH NL 430MM BENT IN THE LOWER URETER DURING ADVANCEMENT. THE PATIENT HAD A SPLINTED URETER, THE URETER WAS TAUT (BUT NOT TOO TAUT ACCORDING TO HER STATEMENT). THE REMOVED THE URS AFTER SHE HAD NO PICTURE ANYMORE. AN INJURY OF THE PATIENT (E.G. BY TEARING OFF THE URETER, ETC.) WAS NOT VISIBLE ACCORDING TO DR. (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    743912 E-LINE URETERORENOSKOP 12 8/9,8CH NL 430MMH URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID FGB RICHARD WOLF GMBH 8703524 04055207020081

    Patients

    Seq Age Sex Outcome Treatment
    1