BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIRANHA

    MDR report key: 12304726 · Received August 10, 2021

    Report

    Report Number
    1418479-2021-00039
    Event Type
    Malfunction
    Date Received
    August 10, 2021
    Date of Event
    June 23, 2021
    Report Date
    October 11, 2021
    Manufacturer
    RICHARD WOLF GMBH
    Product Code
    JCX
    UDI-DI
    04055207011874
    PMA / PMN Number
    K041610
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    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: USER FACILITY WAS CONTACTED THREE TIMES IN AN EFFORT TO COLLECT PATIENT INFORMATION AND USER INFORMATION. 9/24/2021 WE RECEIVED A RESPONSE THAT NO NEW INFORMATION WILL BE PROVIDED. RWMIC CONSIDERS THIS MDR/COMPLAINT OPEN. RWMIC WILL SUBMIT A FOLLOW UP REPORT AFTER THE DEVICE EVALUATION HAS BEEN COMPLETED AND/OR NEW INFORMATION BECOMES AVAILABLE.

    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 PURPOSE OF THIS SUBMISSION IS TO NOTIFY FDA THAT RWMIC CONSIDERS THIS MDR CLOSED. THE DEVICE INVESTIGATION REPORT WAS SUBMITTED ON A PRIOR SUBMISSION AND THERE HAS BEEN NO RESPONSE FROM THE USER FACILITY. RWMIC WILL SUBMIT A FOLLOW UP REPORT SHOULD NEW INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 0

    THE PURPOSE OF THIS REPORT IS TO SHARE THE RESULTS OF THE DEVICE INVESTIGATION. THE DEVICE WAS VISUALLY AND FUNCTIONALLY EVALUATED. ACCORDING TO THE INVESTIGATION REPORT "THE SUCTION PUMP 2208.011 WAS TESTED ACCORDING TO THE WORK INSTRUCTION AAW03-098-0630. THE CUSTOMER'S COMPLAINT COULD NOT BE REPRODUCED ON THE DEVICE. THE GAP DIMENSIONS OF THE VALVE IS 5.0 MM WHICH MEETS THE SPECIFICATIONS. HOWEVER, ACCORDING TO THE CHANGE FOR PK21-0013, THE CHANGE OF VALVE 72319110 IS REQUIRED." NO DEVICE PROBLEM WAS FOUND, THE DEVICE WAS RETURNED WITH A REPLACED VALVE.

    Description of Event or Problem · 0

    THE PURPOSE OF THIS SUBMISSION IS TO CLOSE THIS MEDICAL DEVICE REPORT.

    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 AFTER THE DEVICE EVALUATION HAS BEEN COMPLETED AND/OR NEW INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO RW BY THE USER FACILITY THAT: THIS IS OUR TECHNICIAN'S DESCRIPTION OF THE ISSUE: IT WON'T BUILD SUCTION AT TIMES AND SOMETIMES WHEN IT DOES IT WON'T HOLD SUCTION. OTHER TIMES IT CAN GO THROUGH A CASE WITH NO ISSUES. IT'S BEYOND BEING ABLE TO PIN POINT FROM THE SURFACE LEVEL AS SOME DAYS IT'S FINE AND SOME DAYS IT'S NOT AND FOR THIS REASON I FEEL IT NEEDS TO BE SENT IN AS THE DOCTOR WAS VERY DISAPPOINTED IN THE RESULTS OF THE SURGERY TODAY. HE HAS BEEN PATIENT AS WE TRY TO DO OUR BEST BUT HE NEEDS SOMETHING DONE ABOUT IT. WOLF ONLY OFFERS COMMON TROUBLE SHOOTING OVER THE PHONE, UNPLUGGING RESETTING ETC. THE WOLF REP I SPOKE TO (B)(6) ADVISED IT MAY BE A PINCH VALVE WHICH IS A COMMON ISSUE AND THEY ACTUALLY HAVE MULTIPLE UNITS LATELY GET SENT IN FOR THIS REASON. ADDITIONAL DETAILS THAT WERE REPORTED LATER: WAS THE ITEM BEING USED ON A PATIENT AT THE TIME? YES THE MORCELLATOR WAS BEING USED ON THE PATIENT DURING THE ERROR. WAS THERE INJURY OR ILLNESS TO THE PATIENT BECAUSE OF THE ISSUE? NO INJURY OR ILLNESS WAS THERE INJURY OR ILLNESS TO ANY OTHER PERSONNEL? NO. DID IT CAUSE A DELAY IN THE PROCEDURE? YES WE HAD TO KEEP PAUSING AS THE MACHINE KEPT LOSING SUCTION. DID THE DELAY PUT THE PATIENT AT RISK? ANYTIME THE PATIENT IS UNDER FOR SURGERY TIME IS OF THE ESSENCE. WAS THERE A SIMILAR DEVICE AVAILABLE FOR BACK UP USE? NO. WAS THE PROCEDURE COMPLETED? YES THE PROCEDURE WAS COMPLETED. PLEASE PROVIDE, IN DETAIL, WHAT THE ISSUE WAS WITH YOUR ITEM: THE MORCELLATOR UNIT WILL AT TIMES NOT BUILD SUCTION, IN THIS PARTICULAR CASE IT BUILT SUCTION BUT DURING USE WOULD NOT MAINTAIN SUCTION. THIS WOULD CAUSE THE BLADE TO STOP MOVING AND THE UNIT WOULD START TO BUILD SUCTION FROM THE HALFWAY MARK. ALL BASIC TROUBLE SHOOTING WAS DONE SUCH AS UNPLUGGING, RESETTING, CHECKING TUBING, ETC BUT TO NO AVAIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1199254 PIRANHA SUCTION PUMP JCX RICHARD WOLF GMBH 2208011 04055207011874

    Patients

    Seq Age Sex Outcome Treatment
    1 MOTOR CONTROL UNIT (1418479-2021-00039)2303011