BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONNECTION CABLE WL 3M

    MDR report key: 20368896 · Received October 4, 2024

    Report

    Report Number
    1418479-2024-00008
    Event Type
    Injury
    Date Received
    October 4, 2024
    Date of Event
    September 11, 2024
    Report Date
    October 4, 2024
    Manufacturer
    RICHARD WOLF GMBH
    Product Code
    GEY
    UDI-DI
    04055207066676
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION, RICHARD WOLF CONSIDER THIS CASE TO BE A REPORTABLE "SERIOUS INJURY" DUE TO "ABORTED PROCEDURE".

    Description of Event or Problem · 0

    THE USER FACILITY HAS INFORMED RICHARD WOLF MEDICAL CORPORATION (RWMIC) OF AN ISSUE REGARDING A CONNECTION CABLE WL 3M, PART ID: 8564.851, BATCH# 230372. ACCORDING TO THE RECEIVED INFORMATION, THE USER INDICATED THAT THE CONNECTION BETWEEN THE MOTOR CONTROL UNIT, CONNECTION CABLE, AND THE HANDPIECE HAD BEEN INTERRUPTED. DUE TO IT, THE MOTOR CONTROL UNIT FAILED TO RECOGNIZE THE HANDPIECE. THE CONNECTION CABLE WAS CHECKED, AND NO BENT PINS WERE FOUND. THE REPORTED EVENT HAPPENED ON A THIRD CASE, AT THE BEGINNING OF A HOLMIUM LASER ENUCLEATION OF THE PROSTATE (HOLEP) PROCEDURE BUT PRIOR TO BEING USED ON THE PATIENT. HOWEVER, THERE WAS A REPORTED 15-MINUTE DELAY TROUBLESHOOTING THE DEVICE. THE PROCEDURE WAS NOT COMPLETED, AND THE PATIENT WAS BROUGHT BACK 2 DAYS LATER FOR MORCELLATION. ANOTHER CONNECTION CABLE WAS USED, AND IT WORKED FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1402835 CONNECTION CABLE WL 3M GEY RICHARD WOLF GMBH 8564851 230372 04055207066676

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other HANDPIECE: POWER STICKS.| MOTOR CONTROL UNIT: POWER DRIVE ART1.