BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIRANHA

    MDR report key: 21452907 · Received February 24, 2025

    Report

    Report Number
    9611102-2025-00006
    Event Type
    Malfunction
    Date Received
    February 24, 2025
    Date of Event
    February 6, 2025
    Report Date
    March 27, 2025
    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
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE NEW INFORMATION: B4, G3, G6, H2, H3, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, AND INVESTIGATION CONCLUSIONS), AND H11. THE SUCTION PUMP, 2208011, WAS EXAMINED IN THE SPECIALIST DEPARTMENT. THE SUCTION FUNCTION IS FINE, AS IS THE VACUUM BUILD-UP. ACCORDING TO THE EXAMINATION REPORT, THE INSIDE OF THE SOCKET FOR THE FOOT SWITCH IS NOT AS IT SHOULD BE. THE NOTCH IS TWISTED 90°· TO THE RIGHT AND BROKEN. IT IS POSSIBLE THAT THE FOOT SWITCH 1 PEDAL, 2030108, WAS INSERTED INCORRECTLY AND THEREFORE DID NOT TRIGGER THE SUCTION. THE CAUSE IS DUE TO MECHANICAL OVERLOAD, PROBABLY CAUSED BY EXCESSIVE FORCE BEING APPLIED DURING USE. THE SUCTION PUMP TYPE 2208011 WITH THE SERIAL NUMBER (B)(6), WAS MANUFACTURED ON 29TH MARCH 2023. NO ABNORMALITIES WERE FOUND DURING PRODUCTION, ALL DEVICES PASSED THE FUNCTIONAL CHECKS. RICHARD WOLF GMBH HAS RECEIVED SEVERAL COMPLAINTS IN THE PAST 2 YEARS. THE COMPLAINTS EITHER SHOW CUSTOMER FAULTS DUE TO OPERATING ERROR, OR SPORADIC FAILURE OR WEAR AND TEAR OUTSIDE THE WARRANTY PERIOD, OR DAMAGE DUE TO MECHANICAL INFLUENCES, AS WELL AS NO FUNCTIONAL ERROR ON THE DEVICE. AS THE REVIEW OF ALL AVAILABLE DATA DOES NOT SHOW SIGNS OF SYSTEMATIC ERRORS OR A TREND, NO FURTHER ACTION IS NECESSARY. IN OUR RISK ANALYSIS E3-1: V00, SUCTION PUMPS WITH ACCESSORIES, MANUFACTURING-RELATED, HANDLING-RELATED AND DESIGN­RELATED HAZARDS REGARDING FUNCTIONAL IMPAIRMENT AS WELL AS RISKS DUE TO A PRODUCT THAT CANNOT BE USED WERE CONSIDERED WITH THE CORRESPONDING EXTENT OF DAMAGE AND THE ASSUMED PROBABILITY OF OCCURRENCE AND ASSESSED WITH AN ACCEPTABLE RISK.

    Description of Event or Problem · 0

    ACCORDING TO THE INFORMATION RECEIVED, THE SUCTION PUMP FAILED TO PROVIDE SUFFICIENT SUCTION DURING THE MORCELLATION OF PROSTATE (HOLEP) PROCEDURE. THE USER REPORTED THAT THERE WAS A 30 MINUTE DELAY IN THE PROCEDURE. THERE WAS NO SIMILAR BACK-UP DEVICE, AND THE REMAINING TISSUES HAD TO BE BASKETED OUT. THE PROCEDURE WAS COMPLETED WITHOUT ADDITIONAL MEDICAL TREATMENT. ALL THE OTHER DEVICES USED WITH THE SUCTION PUMP WERE WORKING PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522404 PIRANHA SUCTION PUMP JCX RICHARD WOLF GMBH 2208011 04055207011874

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown TYPE 2030108 FOOTSWITCH 1 PEDAL.| TYPE 2303.011 MOTOR CONTROL UNIT 2303.| TYPE 8564.021 MOTOR HANDPIECE MAX. 6000RPM.