BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIPCONTROL

    MDR report key: 17714329 · Received September 8, 2023

    Report

    Report Number
    9611102-2023-00054
    Event Type
    Injury
    Date Received
    September 8, 2023
    Date of Event
    March 28, 2023
    Report Date
    May 14, 2024
    Manufacturer
    RICHARD WOLF GMBH
    Product Code
    GEI
    PMA / PMN Number
    K170377
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE RF-INSTRUMENT BIPO Ø 2,5MM NL 280MM, PART ID: 4993691, LOT NUMBER 222263, WAS CHECKED BY THE MANUFACTURER (SUTTER GMBH). IT WAS FOUND THAT THERE WAS A SHORT CIRCUIT BETWEEN THE PINS OF THE GENERATOR PLUG. THE SHORT CIRCUIT WAS CAUSED BY SPORADIC, DEFECTIVE MANUFACTURING. AS A CORRECTIVE AND PREVENTIVE MEASURE, THE LENGTH OF THE PINS OF THE DEVICE MARKING WAS SHORTENED FROM 4.5 MM TO 2.5 MM IN ORDER TO MINIMIZE THE PROBABILITY OF ANOTHER SHORT CIRCUIT. ALL DEVICES DELIVERED FROM CALENDAR WEEK 50 / 2023 ONWARDS HAVE THE IMPROVED GENERATOR CONNECTION. A CHECK OF THE COMPLAINTS DATABASE HAS SHOWN THAT THERE HAVE BEEN NO NEW SIMILAR CASES SINCE THIS CORRECTIVE MEASURE WAS IMPLEMENTED. THE CORRECTIVE MEASURE CAN THEREFORE BE DESCRIBED AS "SUCCESSFUL". THE IFU BB-A291-1 / EN / V5.0 / 2022-07 / PK22-0415 CONTAINS SEVERAL SAFETY INSTRUCTIONS AND NOTES. FURTHERMORE, THE USER IS ADVISED TO CHECK THE DEVICE PRIOR AND AFTER EACH USE IN SECTION 8 CHECKS. THE SUBJECT ISSUE OF (ADDITIONAL /OTHER) ANESTHETICS ON PATIENTS IS PRESENT IN THE RISK MANAGEMENT FILE BB2: NON-REUSABLE ELECTRODES, REV.: V00. 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 RF-INSTRUMENT BIPO Ø 2,5MM NL 280MM TYPE 4993691, LOT NO. 222263 WAS MANUFACTURED ON 08/29/2022. THE PRODUCTION ORDER INCLUDED 605 PIECES. NO OTHER COMPLAINTS WERE RECEIVED FROM THE REPORTED LOT.

    Description of Event or Problem · 0

    NEW INFORMATION: DUE TO THE SHORT CIRCUIT IN THE PLUG, IT WAS KNOWN LATER THAT THIS CAUSED AN HOUR DELAY IN THE SURGERY. A SECOND DEVICE COMPLETED THE TREATMENT.

    Description of Event or Problem · 0

    THE USER FACILITY HAS INFORMED RICHARD WOLF GMBH OF AN ISSUE REGARDING AN RF-INSTRUMENT BIPO Ø 2,5MM NL 280MM, PART ID: 4993691, LOT #222263. ACCORDING TO THE RECEIVED INFORMATION, "AS USUAL, I PLAYED IN THE RF PROBE FOR THE OPERATION AND NOTICED THAT "ERR" WAS DISPLAYED ON THE RF GENERATOR AND THE SETTING WAS 46 (NORMAL IS 30). ALSO, THE RF GENERATOR KEPT SOUNDING AN ALARM. I TRIED RESTARTING THE GENERATOR AND PLUGGED AND UNPLUGGED THE PROBE, BUT THE GENERATOR STILL SHOWED "ERR" AND CONTINUED TO ALARM. THEN I OPENED ANOTHER RF PROBE, BUT THE SAME INCIDENT HAPPENED AGAIN. I ALSO NOTICED THAT THE "BICURT 2" BUTTON KEPT FLASHING EVEN AFTER WE PRESSED IT. AFTER A FEW TRIES, THE SECOND PROBE SUDDENLY WORKED AND WE WERE ABLE TO USE IT FOR A WHILE BEFORE IT INDICATED AN ERROR AGAIN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    615425 TIPCONTROL RF-INSTRUMENT BIPO Ø 2,5MM NL 280MM GEI RICHARD WOLF GMBH 4993691 222263

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other