BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 12518809 · Received September 23, 2021

    Report

    Report Number
    1418479-2021-00043
    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
    FJL
    UDI-DI
    04055207057148
    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. DEVICE INVESTIGATION: ACCORDING TO THE RESULTS OF THE DEVICE INVESTIGATION, THE CONNECTION TUBE (8170.6554) WAS TESTED (USING VISUAL AND FUNCTIONAL METHODS), ALSO IN COMBINATION OF DEVICES FROM CMPT 21-00330 A AND C (MDRS 1418479-2021-00042, -00044. NO DEVICE PROBLEM WAS FOUND. THE CUSTOMER'S COMPLAINT COULD NOT BE REPRODUCED ON THE DEVICE. THE DEVICE WAS RETURNED TO THE CUSTOMER. THE REPORTED CONDITION WAS NOT CONFIRMED. 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
    1421312 NA CONNECTION TUBE RECTO PUMP FJL RICHARD WOLF GMBH 81706554 1400817 04055207057148

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Other FOOTSWITCH2030108| LASER MASTERPULSE HOLIUM FORTEC| PIRANHA SUCTION PUMP2208011