BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONNECTION CABLE WL 3M

    MDR report key: 18230164 · Received November 29, 2023

    Report

    Report Number
    9611102-2023-00070
    Event Type
    Injury
    Date Received
    November 29, 2023
    Date of Event
    November 3, 2023
    Report Date
    December 11, 2023
    Manufacturer
    RICHARD WOLF GMBH
    Product Code
    HRX
    PMA / PMN Number
    K030082
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE CONNECTION CABLE WL 3M, PART ID: (B)(6) , BATCH# 153073 WAS INVESTIGATED AT RICHARD WOLF GMBH (RWGMBH). WHEN CHECKING THE CONNECTION CABLE IN THE SPECIALIST DEPARTMENT ACCORDING TO PA01-001-8624, NO FUNCTIONAL ERROR COULD BE FOUND. THE CABLE WAS SUBJECTED TO A FUNCTIONAL, CONTINUITY, HV AND INSULATION TEST. THE CONNECTION CABLE WAS ALSO TESTED WITH A TEST MOTOR HANDLE ON THE TEST DEVICE 320000.4943 IN ACCORDANCE WITH PA01-001-8874 WITHOUT ANY ERRORS OR ABNORMALITIES. THERE IS CURRENTLY NO FUNCTIONALITY DEFICIENCY. THIS CONNECTION CABLE MEETS OUR SPECIFICATIONS AND CAN CONTINUE TO BE USED WITHOUT ANY PROBLEMS. THE CUSTOMER RECEIVED THIS CONNECTION CABLE AS A SPARE PART ON JULY 19, 2023. HE DID NOT TELL US EXACTLY WHICH DRIVE DEVICE AND HANDPIECE IT WAS USED WITH. THERE ARE TWO IFU'S STORED IN SAP FOR TWO DIFFERENT DRIVE DEVICES, MOTOR CONTROL UNIT - 2303 AND POWER DRIVE ART 1 - 2304. IN GENERAL, THE USER WILL FIND OUT MORE ABOUT THIS IN THE ASSOCIATED INSTRUCTIONS FOR USE, GA-A202-US /EN/ 2020-10 V2.0 / PK20-0329 AND GA-A238-US /EN/ 2020-12 V6.0 / PK20-0352, UNDER CHAPTER 4 IT IS POINTED OUT THAT A VISUAL AND FUNCTIONAL CHECK MUST BE CARRIED OUT BEFORE AND AFTER EACH USE. POSSIBLE DAMAGE AND/OR FUNCTIONAL IMPAIRMENTS CAN BE EASILY RECOGNIZED BY HOSPITAL STAFF IF THESE INSTRUCTIONS ARE FOLLOWED. FURTHERMORE, ERRORS WITH POSSIBLE CAUSES AND SOLUTIONS IN THE IFU'S ARE DESCRIBED IN CHAPTER 8.1 - "TROUBLESHOOTING". THE USER IS ALSO INFORMED IN CHAPTER 1.3.2 OF GA-A202 AND IN CHAPTER 1.5 OF GA-A238 THAT AN EQUIVALENT REPLACEMENT SHOULD BE AVAILABLE DUE TO SPORADIC FAILURES IN THERAPEUTIC APPLICATIONS. IN THE OBSERVATION PERIOD OF 3 YEARS, 2X COMPARABLE CASES WITH "NO ERROR/ DEFECT DETECTABLE - INCOMPREHENSIBLE" OF THIS TYPE 8564.851 WERE REGISTERED. THE ORDER SIZE WITH BATCH 153073 WAS 149 CONNECTION CABLES, OF WHICH (B)(6) UNITS WERE SOLD IN THE PERIOD FROM MARCH 2023 TO SEPTEMBER 2023. UNTIL TODAY WE RECEIVED 2 COMPLAINTS ACCORDING THIS BATCH. DUE TO THIS INFORMATION A GENERAL PRODUCT PROBLEM CANNOT BE ASSUMED. IN OUR RISK ANALYSIS E5-1 (CONTROL DEVICES WITH ACCESSORIES, REV.07 FOR POWER DRIVE ART 1 AND REV.05 FOR POWER CONTROL), MANUFACTURING-RELATED, HANDLING-RELATED AND DESIGN-RELATED HAZARDS WITH REGARD TO FUNCTIONAL IMPAIRMENT, SUCH AS FAILURE OF THE DEVICE OR FUNCTIONAL RESTRICTIONS, AS WELL AS RISKS DUE TO A UNUSABLE PRODUCT IS CONSIDERED WITH THE CORRESPONDING EXTENT OF DAMAGE AND THE ASSUMED PROBABILITY OF OCCURRENCE AND ASSESSED WITH AN ACCEPTABLE RISK. THE OVERALL PROBABILITY OF OCCURRENCE FOR THIS ISSUE REMAINS AT PREVIOUSLY DEFINED LEVELS AND OVERALL RISK OF THE DEVICE REMAINS IN THE ACCEPTABLE CATEGORY.

    Additional Manufacturer Narrative · 0

    THE CONNECTION CABLE WL 3M, PART ID: 8564.851, COMES FROM PRODUCTION BATCH 153073 FROM OUR SUPPLIER TYCO. (B)(4). UNTIL TODAY WE RECEIVED 2 COMPLAINTS ACCORDING TO THIS BATCH. DUE TO THIS INFORMATION A GENERAL PRODUCT PROBLEM CANNOT BE ASSUMED. THE SUPPLIER TYCO HAS CONFIRMED WITH THE COC (CERTIFICATE OF COMPLIANCE) THAT THERE ARE NO SPECIAL CASES, RESTRICTIONS OR EXCEPTIONS FOR THE ENTIRE BATCH AND THAT THE LISTED PRODUCTS COMPLY WITH THE RELEVANT TE CONNECTIVITY SPECIFICATION. ACCORDING TO THE USER FACILITY, ATTENDED HOSPITAL FOLLOWING DAY TO EVALUATE SYSTEM AND TRY AND REPLICATE THE FAULT. INSPECTED HANDPIECE AND FOUND TO BE IN EXCELLENT CONDITION. WHEN MOVING THE HANDPIECE CABLE AROUND, FAULT WAS REPLICATED AND DETERMINED TO BE THE CABLE, NOT THE HANDPIECE.

    Description of Event or Problem · 0

    THE USER FACILITY HAS INFORMED RICHARD WOLF GMBH (RWGMBH) OF AN ISSUE REGARDING A CONNECTION CABLE WL 3M, PART ID: 8564.851, BATCH# 153073. ACCORDING TO THE RECEIVED INFORMATION, THE CONNECTION CABLE FAILED DURING THE OPERATION: "SURGEON WAS MORCELLATING THE PROSTATE TISSUE WHICH HAD PREVIOUSLY BEEN RESECTED VIA HOLEP LASER RESECTION. HANDPIECE REPEATEDLY STOPPED WORKING UNTIL SURGEON DEEMED IT UNSAFE TO CONTINUE. HE COMPLETED THE PROCEDURE WITH BI-POLAR RESECTION. THERE WAS AN EXTENSION OF THE OPERATING TIME BY 1 HOUR." ACCORDING TO THE USER FACILITY, THE PATIENT WAS NOT INJURED OR AT RISK AND NO ADDITIONAL, UNSCHEDULED MEDICAL MEASURES HAD TO BE TAKEN. THERE WERE NO UNEXPECTED SIDE EFFECTS EITHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    983686 CONNECTION CABLE WL 3M HRX RICHARD WOLF GMBH 8564851 153073

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other