BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIRANHA

    MDR report key: 12518826 · Received September 23, 2021

    Report

    Report Number
    1418479-2021-00044
    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
    04055207054734
    PMA / PMN Number
    K042523
    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 #2 IS TO PROVIDE FDA WITH MISSING INFORMATION, NEW INFORMATION (RESULTS OF THE DEVICE EVALUATION), AND CHANGED INFORMATION. NEW INFORMATION: THE FOLLOWING FIELDS HAVE NEW INFORMATION: B5, G2, H2, H7, H10. CHANGED INFORMATION: THE FOLLOWING FIELDS HAVE CHANGED INFORMATION: H3. DEVICE INVESTIGATION: ACCORDING TO THE RESULTS OF THE DEVICE INVESTIGATION, THE FOOT SWITCH (2030.108) WAS TESTED (USING VISUAL AND FUNCTIONAL METHODS), ALSO IN COMBINATION OF DEVICES FROM CMPT 21-00330 A AND B (MDRS 1418479-2021-00042, -00043. NO DEVICE PROBLEM WAS FOUND. THE CUSTOMER'S COMPLAINT COULD NOT BE REPRODUCED ON THE DEVICE. THE DEVICE WAS RETURNED TO THE CUSTOMER. RWMIC CONSIDERS THIS MDR CLOSED. RWMIC WILL SUBMIT A FOLLOW UP REPORT WHEN 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 #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.

    Description of Event or Problem · 0

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

    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.

    Additional Manufacturer Narrative · 1

    RWMIC IS SUBMITTING THIS REPORT ON BEHALF OF RICHARD WOLF (B)(4). 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 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
    1421334 PIRANHA FOOTSWITCH 1 PEDAL JCX RICHARD WOLF GMBH 2030108 04055207054734

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Other CONNECTING TUBE8170.6554| LASER MASTERPULSE HOLIUM FORTEC| PIRANHA SUCTION PUMP2208011