BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIRANHA

    MDR report key: 12518779 · Received September 23, 2021

    Report

    Report Number
    1418479-2021-00042
    Event Type
    Malfunction
    Date Received
    September 23, 2021
    Date of Event
    August 26, 2021
    Report Date
    December 6, 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
    NURSE
    Health Professional
    Yes

    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 NEW AND CHANGED INFORMATION. NEW INFORMATION: THE FOLLOWING FIELDS HAVE NEW INFORMATION: SECTION A, B3 - B5, D8, D10, G2, G3, G6, H2, H6, H8, H10. CHANGED INFORMATION: THE FOLLOWING FIELDS HAVE CHANGED INFORMATION: E1, 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. FOLLOW-UP REPORT #2 IS TO PROVIDE FDA WITH MISSING INFORMATION, NEW INFORMATION (RESULTS OF THE DEVICE EVALUATION), AND CHANGED INFORMATION. DEVICE INVESTIGATION: RWMIC RECEIVED THE RESULTS OF THE DEVICE INVESTIGATION. IT IS REPORTED BY THE MANUFACTURER THAT "THE SUCTION PUMP 2208.011 WAS TESTED ACCORDING TO THE WORK INSTRUCITON (AAW03-098-0630, ALSI IN COMBINATION OF DEVICES FROM COMPLAINT (B)(4) (MDRS 1418479-2021-00043, - 00044). THE CUSTOMER'S COMPLAINT COULD NOT BE REPRODUCED ON THE DEVICE. THE GAP DIMENSION OF THE VALVE MEETS THE SPECIFICATIONS, ACCORDING TO THE CHANGE FORM PK21-0013, NO ACTIONS ARE REQUIRED." THE DEVICE WAS EVALUATED USING VISUAL AND FUNCTIONAL METHODS. THE REPORTED CONDITION WAS NOT CONFIRMED, THE DEVICE MEETS SPECIFICATIONS. THE DEVICE WAS RETURNED. RWMIC CONSIDERS THIS MDR CLOSED. 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 REPORT THE ADDITIONAL INFORMATION RECEIVED FROM THE USER FACILITY. DESCRIBE EVENT: HOLEP PUMP NOT PROVIDING SUCTION, MAKES IT DIFFICULT TO MORCELLATE THE PROSTATE. THE DEVICE MALFUNCTION INCREASED LENGTH OF CASE.

    Description of Event or Problem · 0

    THE PURPOSE OF THIS SUBMISSION IS TO REPORT THE RESULTS OF THE DEVICE INVESTIGATION. PLEASE SEE MANUFACTURERS NARRATIVE.

    Additional Manufacturer Narrative · 1

    RWMIC IS SUBMITTING THIS REPORT ON BEHALF OF RICHARD WOLF GMBH. (B)(4) 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 BY THE USER FACILITY: NOT SUCTIONING. WE'VE REACHED OUT TO THE USER FACILITY FOR ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1421311 PIRANHA SUCTION PUMP JCX RICHARD WOLF GMBH 2208011 04055207011874

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Other CONNECTING TUBE8170.6554| FOOTSWITCH2030108| LASER MASTERPULSE HOLIUM FORTEC