BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIRANHA

    MDR report key: 12518896 · Received September 23, 2021

    Report

    Report Number
    1418479-2021-00041
    Event Type
    Malfunction
    Date Received
    September 23, 2021
    Date of Event
    August 24, 2021
    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
    IN, 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 #2 IS TO PROVIDE FDA WITH MISSING INFORMATION. MISSING INFORMATION: USER FACILITY THROUGH THE SALES REP IN AN EFFORT TO COLLECT PATIENT INFORMATION AND USER INFORMATION. ACCORDING TO THE SALES REP, (B)(6) 2021, NO FURTHER INFORMATION WILL BE PROVIDED. WHILE RWMIC CONSIDERS THIS MDR CLOSED, SHOULD WE RECEIVE NEW INFORMATION ABOUT THIS CASE A NEW REPORT WILL BE SUBMITTED TO THE FDA..

    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 NEW INFORMATION. THE FOLLOWING FIELDS HAVE NEW INFORMATION: B4, B5, G2 - 3, G6, H6, H10. RWMIC CONSIDERS THIS MDR OPEN. RWMIC IS ATTEMPTING TO GET ADDITIONAL INFORMATION FROM THE USER FACLITY AND THE SALES REP ABOUT THE DEVICE MALFUNCTION/PROCEDURE. RWMIC WILL SUBMIT A FOLLOW UP REPORT WHEN NEW INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    THE PURPOSE OF THIS SUBMISSION IS TO CLOSE THIS MDR. PLEASE SEE MANUFACTURERS NARRATIVE.

    Description of Event or Problem · 0

    THE PURPOSE OF THIS SUBMISSION IS TO REPORT THE RESULTS OF THE PRODUCT HISTORY EVALUATION. THE DEVICE WAS NOT RETURNED TO RW SO AN INVESTIGATION REPORT - PRODUCT HISTORY EVALUATION WAS COMPLETED. RW GMBH REPORTS THAT: "IN THE PAST THREE YEARS (>01/01/2018), RICHARD WOLF GMBH HAS RECEIVED 29 COMPLAINTS INCLUDING THE CURRENT COMPLAINT (B)(4) REGARDING THE 2208011 SUCTION PUMP WITH VARIOUS DAMAGES AND CAUSES OUTSIDE THE USA. DUE TO POSSIBLE, SPORADIC FAILURES, IN THE GA-A252, THE USER IS ADVISED IN CHAPTER 1.3 THAT AN EQUIVALENT REPLACEMENT MUST BE AVAILABLE WHEN USED FOR THERAPEUTIC APPLICATIONS. FROM THE EVALUATION OF THE AVAILABLE INFORMATION, THERE IS NO DIRECT PATIENT RISK. THE SUCTION PUMP IS EQUIPPED WITH AUTOMATIC FUNCTION CONTROLS WHICH AUTOMATICALLY DETECT AND REPORT VARIOUS ERRORS. FAULTS THAT OCCUR DURING THE SELF-TESTS OR DURING OPERATIONS ARE RECORDED.

    Additional Manufacturer Narrative · 1

    (B)(4). RWMIC WILL SUBMIT A FOLLOW UP REPORT AFTER THE DEVICE EVALUATION OR PRODUCT HISTORY EVALUATION HAS BEEN COMPLETED AND/OR NEW INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO RICHARD WOLF THAT "THE UROLOGY TEAM CONTINUES TO EXPERIENCE ISSUES WITH THE WOLF MORCELLATOR. ON TUESDAY ((B)(6) 2021) IT WOULD NOT SUCTION RELIABLY. IT WOULD SUCTION FOR FIVE SECONDS AND THEN STOP, AND THEN I WOULD HAVE TO RE-EVACUATE THE SYSTEM AT WHICH POINT IT WOULD SUCK FOR FIVE MORE SECONDS." ADDITIONAL DETAILS REPORTED BY THE SALES REP: I WAS NOT ACTUALLY PRESENT AT THE CASE BUT INFORMED OF THE ISSUE VIA EMAIL FROM THE UROLOGY COORDINATOR. THEY HAVE TWO SYSTEMS AND 5 HANDLES OF WHICH NEITHER SN WAS RECORDED WITHOUT BEING THERE I CANNOT SAY FOR SURE BUT I'VE BEEN TO SIMILAR CASES WHERE SUCTION WAS A PROBLEM AND IT CAN ADD SEVERAL UNINTENDED MINUTES TO A CASE. THERE ARE SEVERAL DIFFERENT VARIABLES TO CHECK WITH LOSS OF SUCTION BUT THE GO-TO FIX IS DEPRESSING THE BLACK BUTTON. I WAS TOLD THAT THIS FACILITY HAS ALSO RESORTED TO REMOVING THE FLEXIBLE PORTION FROM THE HOUSING AND HAVE PROCEEDED THROUGH BY MANUALLY STRETCHING THE TUBING UNTIL MORCELLATION IS CONCLUDED. HOWEVER, IF MORCELLATING AT THE MOST COMMON SPEED OF 1500, THE EXPECTED RATE IS 25G/MIN AND NEED TO TROUBLESHOOT SEVERAL TIMES TO RE-ESTABLISH THEN WHAT SHOULD'VE TAKEN AROUND 4MIN CAN BE FAR SURPASSED IN WASTED WAITING...WAITING THAT DID NOT EXIST (AS OF A COUPLE YEARS AGO). DID THE PATIENT REQUIRED ADDITIONAL TREATMENT OR CARE DURING THE DELAY OR AS A RESULTS OF THE DELAY? NOT TO MY KNOWLEDGE WAS THE SCHEDULED PROCEDURE COMPLETED? TO MY KNOWLEDGE YES. UNFORTUNATELY AT THIS TIME I DON'T KNOW WHICH MACHINE IT WAS TO SEND BACK. THERE ARE SOME THAT BELIEVE THESE SUCTION ISSUES ORIGINATE FROM THE HANDLES INSTEAD SO I WILL BE DOING MORE FOLLOW UP TO SEE IF I CAN DETERMINE WHICH TO BE THE CASE AT THE VA. ADDITIONAL DETAILS COLLECTED: WILL THE DEVICE BE RETURNED? NO. WAS THE DEVICE BEING USED ON A PATIENT WHEN THE REPORTING ISSUE OCCURRED? YES. 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? YES. DID THE DELAY PUT THE PATIENT AT RISK? UNKNOWN. WAS THERE A SIMILAR BACK-UP DEVICE AVAILABLE FOR USE? YES. WAS THE SCHEDULED PROCEDURE COMPLETED? YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1420164 PIRANHA SUCTION PUMP JCX RICHARD WOLF GMBH 2208011 04055207011874

    Patients

    Seq Age Sex Outcome Treatment
    1