BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 15314829 · Received August 29, 2022

    Report

    Report Number
    9611102-2022-00044
    Event Type
    Malfunction
    Date Received
    August 29, 2022
    Date of Event
    August 8, 2022
    Report Date
    February 23, 2023
    Manufacturer
    RICHARD WOLF GMBH
    Product Code
    HWE
    UDI-DI
    04055207038154
    PMA / PMN Number
    K080617
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    RWMIC IS SUBMITTING THIS REPORT ON BEHALF OF THE MANUFACTURER RICHARD WOLF GMBH. RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION IS THE IMPORTER OF THIS DEVICE. RW GMBH CONSIDERS THIS MDR OPEN. AS SOON AS THE EXAMINATION IS COMPLETED, RW GMBH WILL SEND A FOLLOW-UP REPORT.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE USER CLAIMING THAT WITHIN A FEW MONTHS, ANOTHER COMPARABLE CASE (PREVIOUS MDR 9611102-2022-00024 / (B)(4)) OCCURRED WITH A RESECTOR FROM THE SAME BATCH. IN BOTH CASES, THE INNER KNIFE GOT CAUGHT IN THE WINDOW OF THE OUTER KNIFE DURING THE ROTATIONAL MOVEMENT. DUE TO THE ABRUPT STOP OF THE INNER KNIFE, THE LOAD LIMIT WAS SUBSEQUENTLY EXCEEDED AND ULTIMATELY A SECTION BROKE OFF. IN BOTH CASES, THE SECTION COULD BE REMOVED FROM THE PATIENT. THE USER FACILITY HAS CONFIRMED LATER THAT THERE WAS NO SERIOUS INJURY FOR THE PATIENT. DURING THE INSPECTION OF THE RESECTOR TOOTHED Ø 2MM 899710032, BATCH # 0608202102 BY RICHARD WOLF GMBH, IT IS DETERMINED IN ACCORDANCE WITH TEST INSTRUCTIONS THAT THE SECTION BROKE OFF DUE TO USING EXCESSIVE FORCE AND PRESSURE ON THE DEVICE. THE RESECTOR TOOTHED Ø 2MM 899710032, BATCH # 0608202102 WAS PRODUCED ON 06/AUG/2021, THE BATCH CONSISTED OF 22 RESECTORS. IN TOTAL, 4 RESECTORS WERE DELIVERED TO THE CUSTOMER, LAST DELIVERY OF 2 RESECTORS WAS ON 13/JUL/2022. IN THE REVIEW PERIOD OF 01/JAN/2019 AND 12/OCT/2022, THERE WAS NO FURTHER COMPLAINTS REGARDING THE RESECTOR EXCEPT THE 2 COMPLAINTS FROM THIS USER. THE IFU GA-A238-US / EN / 2020-12 V6.0 / PK20-0352 CONTAINS SEVERAL SAFETY NOTES OF AVOIDING EXCESSIVE FORCE IN USE OF THE DEVICE IN SECTION 1.5 GENERAL NOTES AND INSTRUCTIONS FOR USE AND IN SECTION 5.4 OPERATION OF DEVICE. THE SUBJECT ISSUE OF AVOIDING EXCESSIVE FORCE IN USE OF THE DEVICE IS PRESENT IN THE RISK MANAGEMENT FILE E5-4 - REUSABLE TOOLS, REV. 05. THE OVERALL PROBABILITY OF OCCURRENCE FOR THIS ISSUE REMAINS AT PREVIOUSLY DEFINED LEVELS AND OVERALL RISK OF THE DEVICE REMAINS IN THE ACCEPTABLE CATEGORY.

    Description of Event or Problem · 0

    RICHARD WOLF GMBH COMPLAINT REFERENCE (B)(4). THE USER INFORMED RICHARD WOLF THAT THE TIP OF THE SHAVERBLADE BROKE OFF INTRAOPERATIVELY. THE BROKEN TIP WAS RECOVERED. THIS RESULTED IN AN EXTENSION OF THE SURGERY TIME BY 45 MINUTES. THE APPLICATION WAS COMPLETED WITH ANOTHER SHAVER. RWGMBH AWARENESS DATE, (B)(6) 2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2614638 NA RESECTOR TOOTHED Ø 2MM HWE RICHARD WOLF GMBH 899710032 0608202102 04055207038154

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other