BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHARK

    MDR report key: 19666367 · Received July 3, 2024

    Report

    Report Number
    9611102-2024-00023
    Event Type
    Injury
    Date Received
    July 3, 2024
    Date of Event
    June 18, 2024
    Report Date
    July 3, 2024
    Manufacturer
    RICHARD WOLF GMBH
    Product Code
    FJL
    UDI-DI
    04055207019672
    PMA / PMN Number
    K062720
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    RICHARD WOLF GMBH (RW) PERFORMED AN EVALUATION OF THE REPORTED DEVICE, OUTER SHEATH RESECTOSCOPE 26FR, PART ID: 8675426, LOT# 1381365, TOGETHER WITH THE COMPLETE DEVICE SYSTEM USED AT TIME OF SURGERY. THE EXAMINATION SHOWED THAT ALL THE DEVICES USED IN THE SYSTEM EXHIBITED A SEVERE KINK (BENT) AT THE SAME POINT. APPARENTLY, THIS WAS DUE TO EXCESSIVE MECHANICAL OVERLOAD WHEN DEVICES WERE ASSEMBLED. IN THE INSTRUCTIONS FOR USE (GA-D374 / EN / US / V1.0 / 2024-03 /), THE USER IS MADE AWARE OF THE LIMITED STABILITY OF THE PRODUCTS AND IS WARNED AGAINST APPLYING STRONG FORCE. AS IT TURNED OUT, MEDWORX GMBH HAS REPAIRED THE INNER SHAFT, 8675324, AND THE WORKING ELEMENT, 8680205, OF THE DEVICE. MEDWORX GMBH IS NOT AUTHORIZED BY RW TO CARRY OUT REPAIRS OR SERVICE ON RW PRODUCTS. THIS IS AN UNAUTHORIZED AND INCOMPREHENSIBLE REPAIR. FOR THIS REASON, THESE DEVICES NO LONGER CORRESPOND TO THE DESIGN AND NO LONGER COMPLY WITH RICHARD WOLF GMBH SPECIFICATIONS. THEREFORE TO BE TREATED AS THIRD-PARTY DEVICE. DUE TO THIS REASON, RW CANNOT MAKE ANY FURTHER EVALUATIONS OR OTHER STATEMENTS. ACCORDING TO THE INVESTIGATION RESULTS, RW CANNOT IDENTIFY ANY PRODUCT RISK IN THIS CASE, AS DEVICES OF THE SYSTEM USED HAVE BEEN MODIFIED BY UNAUTHORIZED REPAIRS. THE DEVICE NO LONGER COMPLIES WITH RICHARD WOLF SPECIFICATIONS AND IS THEREFORE TREATED AS A THIRD-PARTY DEVICE WITHIN THE SCOPE OF THE (B)(4) MDR (B)(4).

    Description of Event or Problem · 0

    RICHARD WOLF GMBH HAS BEEN INFORMED OF AN ISSUE REGARDING AN OUTER SHEATH RESECTOSCOPE 26FR, PART ID: 8675426, LOT# 1381365. ACCORDING TO THE RECEIVED INFORMATION, "WHEN PERFORMING A TRANSURETHRAL RESECTION (TUR) OF THE BLADDER, THE SHAFT OF THE DEVICE WAS BENT. THIS RESULTED IN A LESION OF THE URETHRA. AS A RESULT, THE OPERATING TIME WAS EXTENDED BY 2 HOURS AND ADDITIONAL UNSCHEDULED MEDICAL MEASURES HAD TO BE TAKEN." THE SCHEDULED SURGICAL PROCEDURE WAS COMPLETED AND NO ADDITIONAL SURGERY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    759366 SHARK OUTER SHEATH RESECTOSCOPE 26FR FJL RICHARD WOLF GMBH 8675426 1381365 04055207019672

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Other 8654522: OPTICS BLUE 30° 0 4MM NL 299MM| 8675324: INNER SHAFT FOR RESECTOSCOPE 24CH| 8680205: WORKING ELEMENT ACTIVE BIPO 0/12/30°