BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIRANHA

    MDR report key: 20566608 · Received October 30, 2024

    Report

    Report Number
    9611102-2024-00036
    Event Type
    Injury
    Date Received
    October 30, 2024
    Date of Event
    October 17, 2024
    Report Date
    December 3, 2024
    Manufacturer
    RICHARD WOLF GMBH
    Product Code
    JCX
    UDI-DI
    04055207054734
    PMA / PMN Number
    K042523
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    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 DEVICE SYSTEM INVOLVED IN THE INCIDENT WHICH CONSISTED OF A SUCTION PUMP (B)(6), MOTOR CONTROL UNIT (B)(6)), FOOT SWITCH 1 PEDAL (B)(6), 2 CONNECTION CABLES ((B)(6), AND 2 MOTORIZED HANDPIECES (B)(6) WERE TESTED IN THE SPECIALIST DEPARTMENT AT RWGMBH. THE REPORTED DEVICE FOOT SWITCH 1 PEDAL, 2030108/(B)(6) WAS FOUND WITH NO ERRORS. THE OVERALL INVESTIGATION FINDINGS FOR THE ENTIRE SYSTEM, INCLUDING ONE OF THE MOTORIZED HANDPIECES (B)(6) WITH SN (B)(6), SHOWED NO DEFECTS AND FUNCTIONED PERFECTLY. HOWEVER, THE OTHER MOTORIZED HANDPIECE (B)(6) WITH SN (B)(6), WAS FOUND THAT THE MAGNET IN THE MAGNET COVER WAS CORRODED. THIS MEANS THAT THE VALVE PROVIDED FOR THIS PURPOSE COULD NOT BE PROPERLY LOCKED IN PLACE, THUS IMPAIRING THE SUCTION FUNCTION. IN ADDITION, A CRACK WAS DISCOVERED IN THE WELD SEAM ON THE SUCTION PIPE. BOTH DEFECTS MAY HAVE CAUSED THE SUCTION FUNCTION TO FAIL. THE INSTRUCTIONS FOR USE, IFU GA-A202 / EN / V13.0 / 2023-08 / PK23-0005, CONTAINS SEVERAL SAFETY CHECKS AND INFORMATION REGARDING "LOOSE OR DAMAGE PARTS" IN SECTION 5 CHECKS AND SECTION 5.1 VISUAL INSPECTIONS. ALSO, INSTRUCTIONS TO CHECK DEVICES FOR "COMPLETENESS AND CORROSION" WERE STATED. FURTHERMORE, IT WAS FOUND THAT A VALVE WAS USED WITH BOTH HANDLES; ACCORDING TO THE INSTRUCTIONS FOR USE "GA-A202 / EN / V13.0 / 2023-08 / PK23-0005", A "SEALING INSERT - OPEN" IS PROVIDED FOR UROLOGICAL USE, SO THAT THE SUCTION FUNCTION IS PERMANENTLY ENSURED. SECTION 6.2.8 POWER STICK M4 WITH OPEN SEALING INSERT, EXPLAINS THE POSITIONING OF THE ROTARY BLADE AND THE OPEN SEALING INSERT. IN SUMMARY, WE CAN SAY THAT THE ERRORS DESCRIBED BY THE CUSTOMER (SUCTION FUNCTION AND ROTATION OF THE BLADES) COULD ONLY BE PARTIALLY REPRODUCED. THE PROBLEM WITH THE SUCTION FUNCTION CAN OCCUR WITH THE MOTORIZED HANDLE WITH THE SN (B)(6) IN THE EVENT OF UNFAVORABLE HANDLING AND THE DEFECTS FOUND. HOWEVER, THE FUNCTION OF THE BLADES COULD BE ENSURED WITH BOTH MOTORIZED HANDLES. WE THEREFORE CONSIDER THIS CASE TO BE A "SPORADIC FAILURE", AND THE CAUSE OF THE FAULT CANNOT BE TRACED. POSSIBLE RISKS SUCH AS FUNCTIONAL FAILURE OF THE PRODUCT/PRODUCT COMPONENTS WERE CONSIDERED IN THE RISK ASSESSMENT E3-1, V00: "SUCTION PUMPS WITH ACCESSORIES", UNDER "CHEMICAL HAZARDS: ANESTHETIC AGENTS, ADMINISTRATION OF (ADDITIONAL/OTHER) ANESTHETIC AGENTS TO PATIENT", AND ASSESSED AS ACCEPTABLE WITH THE CORRESPONDING SEVERITY AND PROBABILITY OF OCCURRENCE.

    Additional Manufacturer Narrative · 0

    THE EVENT IS FILED UNDER RICHARD WOLF GMBH COMPLAINT ID: (B)(4).

    Description of Event or Problem · 0

    ACCORDING TO THE INFORMATION RECEIVED, A HOLMIUM LASER ENUCLEATION OF THE PROSTATE (HOLEP) AND TRANSURETHRAL RESECTION OF THE PROSTATE (TURP) PROCEDURE WAS SCHEDULED. IT WAS REPORTED THAT DURING MORCELLATION, THE SUCTION FAILED ON ONE OF THE HANDPIECES. THE HANDPIECE WAS REPLACED, AND THE SUCTION IS WORKING. HOWEVER, WITH THE SECOND HANDPIECE, THE MORCELLATOR BLADE NO LONGER TURNED. THE BLADE WAS REPLACED 4 TIMES, WITHOUT SUCCESS. ALL ATTEMPTS TO TROUBLESHOOT, EVEN WITH GUIDANCE FROM A SERVICE TECHNICIAN, WERE UNSUCCESSFUL. DUE TO IT, THE SCHEDULED OPERATION WAS ABORTED. THE PATIENT MUST BE READMITTED WHEN THE DEVICE IS READY FOR USE AGAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1725255 PIRANHA FOOTSWITCH 1 PEDAL JCX RICHARD WOLF GMBH 2030108 04055207054734

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Other CONNECTION CABLE WL 3M, BATCH# 100157, (B)(6).| PIRANHA SUCTION PUMP 2208, SN (B)(6).| POWER CONTROL 2303, SN (B)(6).| POWER STICK M4 (8564.121) SN (B)(6).