BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HF-RESECTION ELECTRODE "PLASMALOOP", LOOP, LARGE, 24 FR., 12°-30°, ESG TURIS

    MDR report key: 18389723 · Received December 23, 2023

    Report

    Report Number
    9610773-2023-03751
    Event Type
    Injury
    Date Received
    December 23, 2023
    Date of Event
    November 28, 2023
    Report Date
    July 25, 2024
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    FAS
    UDI-DI
    14042761085363
    PMA / PMN Number
    K171965
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION, BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS, THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. IT HAS BEEN OVER 1 YEAR, SINCE THE SUBJECT DEVICE WAS MANUFACTURED. BASED ON THE RESULTS OF THE INVESTIGATION, IT HAS BEEN DETERMINED, THAT THERE IS NO RELATIONSHIP BETWEEN THE REPORTED ADVERSE EVENT AND THE SUBJECT DEVICE. THE EVENT CAN BE DETECTED/PREVENTED, BY FOLLOWING THE INSTRUCTIONS FOR USE (IFU), WHICH STATE: ¿A SUITABLE REPLACEMENT DEVICE MUST BE PROVIDED, DURING AN APPLICATION¿. THIS SUPPLEMENTAL REPORT INCLUDES A CORRECTION TO D9, FROM THE INITIAL MEDWATCH. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION. THE ELECTRODE DISTAL END WAS RECEIVED IN DAMAGED CONDITION. ITS FORK TUBES WERE BENT OUTWARDS AND WIDENED ABOUT 8MM. THE CUTTING LOOP WAS SEVERELY BENT, BUT NO CHARRED MARKS OBSERVED ON THE DISTAL INSULATION TUBES. AFTER ASSEMBLING THE ELECTRODE INTO A TEST WORKING ELEMENT WA22367A, AND CHECKED THAT THE DISTANCE BETWEEN OUR TEST TELESCOPE WA2T430A AND THE NONINSULATED DISTAL TIP OF THE HF-RESECTION ELECTRODE IS APPROXIMATELY 3MM WHICH IS WITHIN SPECIFICATIONS (PER IFU: AT LEAST 2MM). THE HF CABLE WAS THEN CHECKED WITH CUSTOMER GENERATOR ESG-400 (B)(4) AND RECOGNIZED DISPLAYING SALINE MODE WITH DEFAULT SETTINGS CUT 200W/EFFECT2 AND OAG 120/EFFECT2. DURING ACTIVATION ON EITHER SALINE CUT OR COAGULATION MODE WITH THE CUTTING LOOP SUBMERGED IN NORMAL SALINE (0.9% NACL) AS IRRIGATION FLUID, THE CUTTING LOOP WAS HEATED UP GENERATING ENERGY, BUT NO LOUD DING/NOISE OR GLITCH WAS OBSERVED. THEREFORE, THE REPORTED COMPLAINT WAS NOT CONFIRMED. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR IF ANY ADDITIONAL INFORMATION IS PROVIDED BY THE USER FACILITY. THIS REPORT HAS BEEN SUBMITTED BY THE IMPORTER UNDER THIS MDR REPORT NUMBER 2429304-2023-00407.

    Description of Event or Problem · 0

    A COMPANY REPRESENTATIVE, ON BEHALF OF THE CUSTOMER, REPORTED A LOUD DING FROM THE HF UNIT "ESG-400" DURING A THERAPEUTIC TRANSURETHRAL RESECTION OF A BLADDER TUMOR. THE DOCTOR WAS USING A BIPOLAR LOOP AND THE ESG-400. WHEN THE DOCTOR HEARD THE LOUD NOISE FROM HF UNIT "ESG-400" THERE WAS A GLITCH AND THE DOCTOR PERFORATED THE BLADDER. THE PATIENT WAS TRANSFERRED TO ANOTHER ROOM FOR A CYSTOGRAM. THE INITIAL CASE WAS ABORTED AND THE EQUIPMENT WAS QUARANTINED. THIS MEDWATCH REQUIRES TWO REPORTS. THE RELATED PATIENT IDENTIFIERS ARE AS FOLLOWS: (B)(6): HF UNIT "ESG-400" .(B)(6): HF-RESECTION ELECTRODE "PLASMALOOP", LOOP, LARGE, 24 FR., 12°-30°, ESG TURIS. THIS MEDWATCH REPRESENTS (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2291439 HF-RESECTION ELECTRODE "PLASMALOOP", LOOP, LARGE, 24 FR., 12°-30°, ESG TURIS RESECTION ELECTRODES WITH HF CABLE FAS OLYMPUS WINTER & IBE GMBH WA22707S 1000123554 14042761085363

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Required Intervention HF UNIT "ESG-400"