BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S-LINE

    MDR report key: 18660542 · Received February 7, 2024

    Report

    Report Number
    9611102-2024-00003
    Event Type
    Malfunction
    Date Received
    February 7, 2024
    Date of Event
    January 15, 2024
    Report Date
    February 7, 2024
    Manufacturer
    RICHARD WOLF GMBH
    Product Code
    FDC
    UDI-DI
    04055207042953
    PMA / PMN Number
    K062720
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE WORKING ELEMENT PASSIVE BIPO 0/12/30°, PART ID: 8680.225, LOT # 1285560 WAS INVESTIGATED AT RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION (RWMIC). THE INVESTIGATION FINDINGS CONFIRMED TRACES OF BURNS INSIDE ELECTRODE LOCK HOUSING AT BOTH H.F.CONNECTING POST AND ELECTRODE LOCK CONNECTOR. THE METAL OF ELECTRODE LOCK CONNECTOR WAS BURNT AND PARTIALLY MELTED. BURNT DEBRIS WERE FOUND INSIDE. ALSO, THERE WERE BURNS ON INNER SURFACE OF SCOPE GUIDE SHAFT. FURTHER INVESTIGATIONS REVEALED THAT THE DAMAGE WAS MOST LIKELY THE RESULT OF AN EXCESSIVELY HIGH CURRENT WHICH SUPER-HEATED THE METAL AND ADHESIVES IN THE DEVICE. THIS EXISTING EVIDENCE IS NOT SUFFICIENT TO CONFIRM THE EXACT CAUSE OF THE EVENT. AN EVALUATION OF THE HISTORY OF THE DEVICE HAS SHOWN THAT THIS WORKING ELEMENT WITH THE BATCH NUMBER 1285560 WAS PRODUCED ON JULY 8, 2015. THERE WERE NO ANOMALIES DURING PRODUCTION AND ALL PARTS PASSED THE FUNCTIONAL TEST. THE COMPLAINTS DATABASE FROM 01/OCT/2015 UNTIL 18/JAN/2024 HAS SHOWN THAT THERE ARE A TOTAL OF 2 SIMILAR COMPLAINTS DISTRIBUTED OVER DIFFERENT BATCHES. · (B)(4): 2/3/2023: MDR 9611102-2023-00019, BATCH# 1474987 · (B)(4): 10/19/2023: MDR 9611102-2023-00065, BATCH# 1499179 IN THE SAME PERIOD, (B)(4) UNITS WERE SOLD, WHICH CORRESPONDS TO A FREQUENCY OF (B)(4)% FOR SIMILAR COMPLAINTS. IN THIS CURRENT CASE WITH THE AFFECTED BATCH NO. 1285560 THERE WAS A 2ND COMPLAINT, BUT WITH DIFFERENT REASON. ON 14/OCT/2016, THE FOLLOWING COMPLAINT WAS SUBMITTED (B)(4), REASON FOR THE COMPLAINT: BREAKAGE OF THE CABLE CONNECTION. THIS FAULT WAS ADDRESSED AS "NOT TRACEABLE", AS A FIXING SCREW WAS MISSING. A GENERAL PRODUCT PROBLEM CAN BE EXCLUDED. IN GENERAL, THE USER IS ADVISED IN THE ASSOCIATED INSTRUCTIONS FOR USE, GA-D342 / EN / US / V11.0 / 2023-08 / PK23-0156 (RW: EN / 2021-03 V16.0 / PK20-0295), UNDER CHAPTER 7 USE - WARNING: HAZARD DUE TO LINE VOLTAGE! CAUTION: HF DEVICES GENERATE HIGH-FREQUENCY ELECTRICAL VOLTAGES AND CURRENTS AS INTENDED. IN ORDER TO AVOID SUCH DAMAGES, CHAPTER 8, RECOMMENDS THAT A VISUAL AND FUNCTIONAL CHECK MUST BE CARRIED OUT BEFORE AND AFTER EACH USE. DO NOT USE THE PRODUCTS IF THEY ARE DAMAGED AND INCOMPLETE OR HAVE LOOSE PARTS. WITH REGARD TO THE HF BIPOLAR CONNECTION CABLE, CHAPTER 8.1.1, STATES TO CHECK FOR DAMAGE TO THE INSULATION AND/OR THE CABLE / PLUG, E.G., CRACKS AND BREAKS. UNDER CHAPTER 8.1.4 ELECTRODES, TO CHECK THE INSULATION AND REPLACE THE ELECTRODES IN THE EVENT OF DAMAGE OR DISTAL WEAR. POSSIBLE HAZARDS WERE CONSIDERED IN THE RISK ASSESSMENT B6-11 REV.04 WITH THE CORRESPONDING EXTENT OF DAMAGE AND PROBABILITY OF OCCURRENCE UNDER "HAZARDS DUE TO NON-USABLE PRODUCT" UNDER "HANDLING-RELATED" AND ASSESSED AS ACCEPTABLE.

    Description of Event or Problem · 0

    A USER FACILITY HAS INFORMED RICHARD MEDICAL INSTRUMENTS CORPORATION (RWMIC) OF AN ISSUE REGARDING A WORKING ELEMENT PASSIVE BIPO 0/12/30°, PART ID: 8680.225, LOT# 1285560. ACCORDING TO THE RECEIVED INFORMATION, AT THE BEGINNING OF A TRANSURETHRAL RESECTION OF BLADDER TUMOR THE MEDICAL DOCTOR, REGISTERED NURSE, AND SURGICAL TECHNOLOGIST REPORTED A LOUD POP FROM THE DEVICE OCCURRED WHILE IN THE PHYSICIAN'S HAND. THIS CAUSED A FEW MINUTES DELAY DURING THE OPERATION. A BACK-UP DEVICE WAS RETRIEVED TO COMPLETE THE SCHEDULED PROCEDURE. THERE IS NO REPORT OF INJURY TO THE PATIENT OR OTHER PERSONNEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1439782 S-LINE WORKING ELEMENT PASSIVE BIPO 0/12/30° FDC RICHARD WOLF GMBH 8680225 1285560 04055207042953

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown PART ID: 46221313US - CUTTING ELECTRODE BIPO 24FR