BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHARK

    MDR report key: 11020631 · Received December 16, 2020

    Report

    Report Number
    1418479-2020-00048
    Event Type
    Malfunction
    Date Received
    December 16, 2020
    Report Date
    September 9, 2021
    Manufacturer
    RICHARD WOLF GMBH
    Product Code
    JOS
    UDI-DI
    04055207049044
    PMA / PMN Number
    K062720
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW-UP REPORT #1 IS TO PROVIDE FDA WITH MISSING INFORMATION, NEW INFORMATION, AND CHANGED INFORMATION. MISSING INFORMATION: THE USER FACILITY WAS CONTACTED THREE TIMES IN AN EFFORT TO COLLECT PATIENT AND OTHER MISSING INFORMATION. ON MARCH 30, 2021 WE RECEIVED A RESPONSE THAT NO FURTHER INFORMATION IS AVAILABLE. RESULTS OF THE DEVICE INVESTIGATION: THE DEVICE WAS VISUALLY AND FUNCTIONALLY EVALUATED AND FOUND TO HAVE A MANUFACTURING DEFECT WHICH WAS CAUSED BY RWMIC IS SUBMITTING THIS REPORT ON BEHALF OF RICHARD WOLF GMBH. RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION IS THE IMPORTER OF THIS DEVICE. RWMIC CONSIDERS THIS MDR CLOSED HOWEVER SHOULD WE RECEIVE ADDITIONAL INFORMATION A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    FOR RESULTS OF THE DEVICE INVESTIGATION SEE THE MANUFACTURERS NARRATIVE.

    Additional Manufacturer Narrative · 1

    RWMIC IS SUBMITTING THIS REPORT ON BEHALF OF RICHARD WOLF (B)(4). RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION IS THE IMPORTER OF THIS DEVICE. RWMIC CONSIDERS THIS MDR/COMPLAINT OPEN. RWMIC WILL SUBMIT A FOLLOW UP REPORT AFTER THE DEVICE EVALUATION HAS BEEN COMPLETED AND/OR NEW INFORMATION BECOMES AVAILABLE. RWMIC WILL REACH OUT TO USER FACILITY TO REQUEST ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    ON NOVEMBER 12TH, 2020, THE USER FACILITY REPORTED THE FOLLOWING TO RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION (RWMIC): DR. (B)(6) HAD 4 MONOPOLAR ELECTRODES THAT LITERALLY BLEW UP IN A TURP CASE. WILL THE DEVICE BE RETURNED? YES. WAS THE DEVICE BEING USED DURING A PROCEDURE WHEN THE ISSUE OCCURRED? YES. WAS THERE ANY INJURY OR ILLNESS TO THE PATIENT DUE TO THE REPORTED ISSUE? UNKNOWN. WAS THERE ANY INJURY OR ILLNESS TO ANY OTHER PERSONNEL DUE TO THE REPORTED ISSUE? NO. DID THE ISSUE CAUSE A DELAY IN THE PROCEDURE BEING PERFORMED? YES. DID THE DELAY PUT THE PATIENT AT RISK? (ONLY APPLICABLE IF THERE WAS A REPORT OF DELAY) YES WAS THERE A SIMILAR BACK-UP DEVICE AVAILABLE FOR USE? YES. WAS THE SCHEDULED PROCEDURE COMPLETED? NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1486992 SHARK CUTTING ELECTRODE MONO 24FR, STERILE, FOR SINGLE USE JOS RICHARD WOLF GMBH 46782425 21002048 04055207049044

    Patients

    Seq Age Sex Outcome Treatment
    1