BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONNECTION CABLE WL 3M

    MDR report key: 20369024 · Received October 4, 2024

    Report

    Report Number
    9611102-2024-00034
    Event Type
    Injury
    Date Received
    October 4, 2024
    Date of Event
    September 11, 2024
    Report Date
    November 14, 2024
    Manufacturer
    RICHARD WOLF GMBH
    Product Code
    GEY
    UDI-DI
    04055207066676
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE NEW INFORMATION: A1, A2, A3A, A5, A6, B4, G3, G6, H2, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, AND INVESTIGATION CONCLUSIONS), H7, AND H11. THE CONNECTION CABLE, 8564.851, WAS INVESTIGATED AND THE REAR PLASTIC OUTER SHEATH OF THE METALLIC PART OF THE PLUG FROM THE MOTOR SIDE WAS FOUND LOOSE AND TWISTED UNCONTROLLABLY. ALSO, THE STRANDS IN THE PLUG WERE BROKEN. THE STRANDS MAY HAVE BEEN BROKEN BY TORSION, WHICH CAN ONLY OCCUR WHEN PLUG IS PULLED OUT UNDER THESE CONDITIONS. WHY THE PLUG WAS LOOSE IS UNKNOWN. BASED ON THIS INFORMATION, THE ROOT CAUSE WAS DETERMINED TO BE A USER ERROR. THE DATE OF MANUFACTURE OF THE CONNECTION CABLE WL 3M, PART ID: 8564.851, BATCH# 230372, IS UNKNOWN. A GENERAL PRODUCT PROBLEM CAN BE RULED OUT. AN EVALUATION OF COMPARABLE CASES/COMPLAINTS FROM THE LAST 10 YEARS DID NOT YIELD ANY. THE INSTRUCTIONS FOR USE, GA-A202-US /EN/ 2020-10 V2.0 / PK20-0329 AND GA-A238-US /EN/ 2020-12 V6.0 / PK20-0352, CONTAINS SEVERAL SAFETY INSTRUCTIONS AND NOTES ON "LOOSE OR DAMAGED PARTS" IN SECTION 4 "CHECKS". IT IS POINTED OUT THAT A VISUAL AND FUNCTIONAL CHECK MUST BE CARRIED OUT BEFORE AND AFTER EACH USE. THE SUBJECT ISSUE OF "DISCONNECTION" IS PRESENT IN THE RISK MANAGEMENT FILE "E5-1: CONTROL UNITS WITH ACCESSORIES" V00. THE OVERALL PROBABILITY OF OCCURRENCE FOR THIS ISSUE REMAINS AT PREVIOUSLY DEFINED LEVELS AND THE OVERALL RISK OF THE DEVICE REMAINS IN THE ACCEPTABLE CATEGORY.

    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
    726151 CONNECTION CABLE WL 3M GEY RICHARD WOLF GMBH 8564851 230372 04055207066676

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Other HANDPIECE: POWER STICKS.| MOTOR CONTROL UNIT: POWER DRIVE ART1.