BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWER CONTROL

    MDR report key: 10779301 · Received November 3, 2020

    Report

    Report Number
    1418479-2020-00042
    Event Type
    Malfunction
    Date Received
    November 3, 2020
    Date of Event
    September 18, 2020
    Report Date
    March 12, 2021
    Manufacturer
    RICHARD WOLF GMBH
    Product Code
    HRX
    UDI-DI
    04055207056653
    PMA / PMN Number
    K030082
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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 IS THE IMPORTER OF THIS DEVICE. USER FACILITY WAS CONTACTED THREE TIMES IN AN EFFORT TO COLLECT PATIENT INFORMATION AND USER INFORMATION. AS OF 03/9/2021, RWMIC HAS NOT RECEIVED A RESPONSE. RWMIC CONSIDERS THIS MDR CLOSED.

    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. THE FOLLOWING SECTIONS INCLUDE NEW OR CHANGED INFORMATION: B4, B5 G3, G6, H2, H3, H6, AND H10. LABELING REVIEW (GA-A252): THE FOOT SWITCH TYP 2030108 MUST NOT BE ACTUATED UNTIL "READY FOR USE" APPEARS ON THE DISPLAY OF THE TYP 2208011, OTHERWISE THE ERROR MESSAGE "FOOTSWITCH IN USE/ DEFECTIVE PLEASE CHECK" APPEARS, SEE GA-A252 CHAPTER 7. I. RWMIC CONSIDERS THIS MDR/COMPLAINT OPEN. RWMIC WILL CONTACT THE USER FACILITY FOR MISSING PATIENT INFORMATION.

    Description of Event or Problem · 0

    RWMIC DEVICE EVALUATION (B)(6) 2021: DURING THE INSPECTION OF THE MOTOR CONTROL UNIT TYPE 2303011 NO DEFECT/ERROR COULD BE DETECTED. THE FOOT SWITCH TYPE 2030108 MUST NOT BE ACTUATED UNTIL "READY FOR USE" APPEARS ON THE DISPLAY OF THE TYPE 2208011, OTHERWISE THE ERROR MESSAGE "FOOTSWITCH IN USE/ DEFECTIVE PLEASE CHECK" APPEARS, SEE GA-A252 CHAPTER 7. I. IT IS HIGHLY PROBABLE THAT THE FOOTSWITCH IS ACTUATED DURING VACUUM BUILDUP OR THAT THE VACUUM IS TOO LOW. PIRANHA MODE OR SUCTION MODE CANNOT BE ACTIVATED ERROR "FOOT SWITCH DEFECTIVE" CHECK FOR CORRECT TUBE CONNECTIONS. THE REPORTED CONDITIONS COULD NOT BE CONFIRMED, THEREFORE NO FURTHER ACTIONS WILL BE CARRIED OUT.

    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. RWMIC WILL SUBMIT A FOLLOW UP REPORT WITH ADDITIONAL INFORMATION AND INVESTIGATION OF THIS COMPLAINT.

    Description of Event or Problem · 1

    ON OCTOBER 5TH, 2020, THE USER FACILITY REPORTED THE FOLLOWING TO RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION (RWMIC): PIRANHA HAND PIECE (SUCTION PUMP) KEPT FAILING TO ACTIVATE, TRIED RESTARTING UNIT BUT THE HAND PIECE WOULD NOT WORK. BRIEFLY SWITCHED TO ANOTHER HAND PIECE AND IT ONLY WORKED INTERMITTENTLY AS WELL. RESTARTED UNIT 5 TIMES, TOOK 3 HOURS TO DO A 30 MIN PROCEDURE. THE SHAVER HANDLE STOPS DURING PROCEDURE, THE UNIT SAYS TREATMENT MODE AND IS NOT EVACUATING WHEN IT STOPS. PLEASE CHECK FOOTSWITCH. THEY HAVE USED MULTIPLE SHAVER HANDLES IN ONE CASE AND THE SAME THING HAPPENED WITH DIFFERENT HANDLES. IT DELAYED THE PROCEDURE BY THREE HOURS, THE PATIENT HAD RECEIVED TWO BLOOD TRANSFUSIONS AS A RESULT. 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? YES 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? NO WAS THE SCHEDULED PROCEDURE COMPLETED? YES

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1245402 POWER CONTROL MOTOR CONTROL UNIT 2303 FOR UROLOGY AND ORTHOPEDICS HRX RICHARD WOLF GMBH 2303011 04055207056653

    Patients

    Seq Age Sex Outcome Treatment
    1 Other