BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-LINE

    MDR report key: 19311138 · Received May 14, 2024

    Report

    Report Number
    9611102-2024-00018
    Event Type
    Injury
    Date Received
    May 14, 2024
    Date of Event
    March 7, 2024
    Report Date
    May 14, 2024
    Manufacturer
    RICHARD WOLF GMBH
    Product Code
    FDC
    UDI-DI
    04055207042953
    PMA / PMN Number
    K062720
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE WORKING ELEMENT PASSIVE BIPO 0/12/30°, PART ID: 8680.225, LOT # 1546598, WAS CHECKED BY THE TECHNICAL DEPARTMENT AT RICHARD WOLF GMBH. THE FOLLOWING FAULT WAS FOUND IN THE LOCK HOUSING, "ELECTRICAL CONTINUITY INTERRUPTED". DUE TO THE AGE OF THE WORKING ELEMENT, APPROX. 10 MONTHS AT TIME OF THE EVENT, AND THE FAULT PATTERN (CONTAMINATION IN THE CLAMPING SLEEVE), WE CAN ATTRIBUTE THIS FAULT TO CLEANING/MAINTENANCE ERRORS. THE COMPLAINT DATA RESEARCH OF THE LAST 3 YEARS HAS SHOWN THAT THERE ARE THREE COMPLAINTS INCLUDING THIS COMPLAINT (B)(4) WITH A SIMILAR FAULT REGARDING MAINTENANCE AND CARE. THE INSTRUCTIONS FOR USE GA-D342 / EN / US / V11.0 / 2023-08 / PK23-0156 (RW: EN / 2021-03 V16.0 / PK20-0295) CONTAIN SEVERAL SAFETY INSTRUCTIONS AND INFORMATION ON REPROCESSING THE DEVICES IN SECTION 9 REPROCESSING AND MAINTENANCE. IN ADDITION, THE USER IS RECOMMENDED TO CHECK THE DEVICE BEFORE AND AFTER EACH USE SEE SECTION 8 CHECKS. THE TOPIC "HAZARD DUE TO PRODUCT COMBINATIONS" HAS BEEN INCLUDED IN THE RISK MANAGEMENT FILE B6 REUSABLE OPTICAL INSERTS, REV: R04. THE OVERALL PROBABILITY OF OCCURRENCE OF THIS ISSUE REMAINS AT THE PREVIOUSLY DEFINED LEVEL AND THE OVERALL RISK OF THE PRODUCT REMAINS IN THE ACCEPTABLE CATEGORY.

    Description of Event or Problem · 0

    RICHARD WOLF GMBH HAS BEEN INFORMED OF AN ISSUE REGARDING A WORKING ELEMENT PASSIVE BIPO 0/12/30°, PART ID: 8680.225, LOT# 1546598. ACCORDING TO THE RECEIVED INFORMATION, DURING A SURGICAL PROCEDURE THE CONDUCTION OF ENERGY THAT GOES FROM THE WORKING ELEMENT TO THE CUTTING HANDLE WAS DEFICIENT. TO COUNTERACT THIS DEFICIENCY THE PARAMETERS OF THE GENERATOR HAD TO BE INCREASED. THIS SOLUTION WORKED DURING THE SURGERY, WHICH ALLOWED THE PROCEDURE TO BE COMPLETED. BECAUSE OF THIS FAILURE, THE SURGERY TIME WAS EXTENDED FOR MORE THAN 60 MINUTES. WITH THE INFORMATION CURRENTLY AVAILABLE TO RWGMBH FROM THE QUESTIONNAIRE ON INCIDENT (B)(4), NO PATIENT INJURY OR PATIENT RISK IS APPARENT. IN ADDITION, NO OTHER UNEXPECTED SIDE EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    925477 S-LINE WORKING ELEMENT PASSIVE BIPO 0/12/30° FDC RICHARD WOLF GMBH 8680225 1546598 04055207042953

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other