BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIRANHA

    MDR report key: 10803378 · Received November 6, 2020

    Report

    Report Number
    1418479-2020-00026
    Event Type
    Malfunction
    Date Received
    November 6, 2020
    Date of Event
    August 19, 2020
    Report Date
    October 13, 2021
    Manufacturer
    RICHARD WOLF GMBH
    Product Code
    JCX
    UDI-DI
    04055207011874
    PMA / PMN Number
    K041610
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    RWMIC IS SUBMITTING THIS REPORT ON BEHALF OF RICHARD WOLF GMBH. RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION IS THE IMPORTER OF THIS DEVICE. FOLLOW-UP REPORT #1 IS TO PROVIDE FDA WITH MISSING INFORMATION, NEW INFORMATION, AND CHANGED INFORMATION. MISSING INFORMATION: THERE ARE NO PATIENT DETAILS, THE DEVICE WAS NOT BEING USED ON A PATIENT AT THE TIME. RWMIC CONSIDERS THIS MDR CLOSED. SHOULD RW RECEIVE NEW INFORMATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    THE PURPOSE OF THIS SUBMISSION IS TO REPORT THE RESULTS OF THE DEVICE EVALUATION/INVESTIGATION. THE DEVICE WAS RECEIVED AND VISUALLY, FUNCTIONALLY AND ELECTRICALLY EVALUATED. THE REPORTED CONDITION WAS NOT CONFIRMED. IT WAS FOUND "THE DEVICE WAS CHECKED, NO ERRORS WERE FOUND. ACCORDING TO THE CHANGE FORM PK21-0013, THE MAGNET VALVE WAS ALSO CHECKED. THE DEVICE IS FROM 2016 AND THERE IS NO ISSUE WITH THE DIMENSION OF THE GAP, IT MEETS SPECIFICATIONS."

    Additional Manufacturer Narrative · 1

    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/COMPLAINT OPEN. THE USER FACILITY AND MANUFACTURER WILL BE CONTACTED FOR ADDITIONAL INFORMATION. UPON RECEIPT OF NEW INFORMATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ON AUGUST 31ST, 2020, THE CLINICAL SPECIALIST REPORTED THE FOLLOWING TO RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION (RWMIC): I WANTED TO GIVE YOU SOME INFORMATION REGARDING THE PIRANHA POWER CONTROL UNIT. THE LOANER #1 UNIT THAT VANDERBILT IS SENDING BACK HAD ISSUES WITH THE CONTROL UNIT FREEZING UP. WHEN I WOULD UNPLUG THE COMMUNICATION CABLE TO ADJUST THE BLADE, THE TOOL WOULD APPEAR BUT NOT THE DOUBLE ARROW BUTTON. I HAD TO TURN THE UNIT OFF AND BACK ON TO GET THE ARROW BUTTON TO POP BACK UP. THE UNIT I HAVE HERE AT THE HOUSE DID THE SAME THING THE OTHER DAY. SO I WAS TAKING A VIDEO OF THIS TO SHOW YOU GUYS WHAT IT WAS DOING. I WILL SEND YOU THE VIDEO. ON THE VIDEO YOU WILL NOTICE A BROWN SPECK ABOVE THE FOOTSWITCH SYMBOL. THAT SPECK WAS INSIDE THE UNIT HEATING UP BUT I DID NOT EVEN NOTICE THE SPOT UNTIL AFTER MY HAND TOUCHED IT AND IT WAS REAL HOT. IT THEN LIT UP AND ALMOST CAUGHT ON FIRE. WILL THE DEVICE BE RETURNED? YES. WAS THE DEVICE BEING USED DURING A PROCEDURE WHEN THE ISSUE OCCURRED? NO. WAS THERE ANY INJURY OR ILLNESS TO THE PATIENT DUE TO THE REPORTED ISSUE? NO. 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? N/A. DID THE DELAY PUT THE PATIENT AT RISK? (ONLY APPLICABLE IF THERE WAS A REPORT OF DELAY) N/A. WAS THERE A SIMILAR BACK-UP DEVICE AVAILABLE FOR USE? N/A. WAS THE SCHEDULED PROCEDURE COMPLETED? N/A. THE INITIAL REPORT FOR THE POWER CONTROLLER (2303011) WAS REPORTED UNDER MDR# 1418479-2020-00025 ON 09/15/2020. HOWEVER, THIS REPORT IS FOR THE ADDITIONAL PRODUCT (SUCTION PUMP) WHICH WAS USED WITH THE REPORTED POWER CONTROLLER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1266050 PIRANHA SUCTION PUMP JCX RICHARD WOLF GMBH 2208011 04055207011874

    Patients

    Seq Age Sex Outcome Treatment
    1