BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENHANCE

    MDR report key: 22509316 · Received July 15, 2025

    Report

    Report Number
    3007593944-2025-00002
    Event Type
    Malfunction
    Date Received
    July 15, 2025
    Date of Event
    June 25, 2025
    Report Date
    August 13, 2025
    Manufacturer
    ASENSUS SURGICAL, INC.
    Product Code
    NAY
    UDI-DI
    00815440021634
    PMA / PMN Number
    K183098
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    DATE OF THE INCIDENT: (B)(6) 2025. DATE OF AWARENESS: 25-JUNE-2025. LOCATION: (B)(6) HOSPITAL, (B)(6). DEVICE NAME: 3MM BIPOLAR INSTRUMENT. ACCORDING TO THE EVENT INFORMATION, DURING THE SIMULATION TRAINING SESSION, 3MM BIPOLAR INSTRUMENT WAS USED WITHOUT ANY PROBLEMS. DURING THE SIMULATION TRAINING, NO ISSUES OR MALFUNCTIONS WITH THE INSTRUMENT WAS OBSERVED. HOWEVER, DURING CLEANING, THE STAFF DISCOVERED THE HINGE TO BE BURNT/DISCOLORED. THE TRAINING WAS PERFORMED ON A SIMULATED ORGAN MODEL MADE OF A WATER BASED GEL. THE COMPLAINANT ALSO REPORTED THAT IT WAS THE FIRST USE OF THE INSTRUMENT, AND THE ESU SETTING WAS 30W. SINCE THE ISSUE OCCURRED DURING TRAINING, THERE WAS NO PATIENT HARM OR SURGICAL CASE IMPACT REPORTED. NO SPARKS WERE IDENTIFIED DURING THE USE OF THE INSTRUMENT. THE INVESTIGATION OF THE ISSUE IS ONGOING.

    Description of Event or Problem · 0

    DATE OF THE INCIDENT: (B)(6) 2025. DATE OF AWARENESS: 25-JUNE-2025. LOCATION: (B)(6) HOSPITAL. DEVICE NAME: 3MM BIPOLAR INSTRUMENT. ACCORDING TO THE EVENT INFORMATION, DURING THE SIMULATION TRAINING SESSION, 3MM BIPOLAR INSTRUMENT WAS USED WITHOUT ANY PROBLEMS. DURING THE SIMULATION TRAINING, NO ISSUES OR MALFUNCTIONS WITH THE INSTRUMENT WAS OBSERVED. HOWEVER, DURING CLEANING, THE STAFF DISCOVERED THE HINGE TO BE BURNT/DISCOLORED. THE TRAINING WAS PERFORMED ON A SIMULATED ORGAN MODEL MADE OF A WATER BASED GEL. THE COMPLAINANT ALSO REPORTED THAT IT WAS THE FIRST USE OF THE INSTRUMENT, AND THE ESU SETTING WAS 30W. SINCE THE ISSUE OCCURRED DURING TRAINING, THERE WAS NO PATIENT HARM OR SURGICAL CASE IMPACT REPORTED. NO SPARKS WERE IDENTIFIED DURING THE USE OF THE INSTRUMENT. THE CUSTOMER USED A 80100088 CABLE (PN X0007819) IN CONJUNCTION WITH A BIPOLAR MARYLAND DISSECTOR X0007309 WITH A VALLEYLAB FT10 ESU. UM-001-00035_US (FROM WHICH THE JAPANESE UM IS BASED) REFERS TO CABLE 80100088 AS COMPATIBLE WITH ONLY 'BIPOLAR SCISSORS'. THEREFORE, A POTENTIAL CABLE INCOMPATIBILITY HAS BEEN NOTICED. THE TESTING TEAM CONFIRMED THE PRESENCE OF SPARKS AT THE CLEVIS DURING THE TEST WHEN THE INSTRUMENT WAS IN CONTACT WITH THE SUBSTRATE (SALINE-SOAKED SPONGE). SPARKS WERE CONFIRMED ON ALL 3 INSTRUMENTS TESTED. THE TESTING TEAM SUSPECTS THAT THE PRESENCE OF ELECTROLYTIC FLUID MAKING CONTACT AT THE CLEVIS OF THE INSTRUMENT COULD HAVE GENERATED THE SPARKS (ALTHOUGH IN A HIGH ELECTROLYTIC ENVIRONMENT, WHICH IS NOT INTENDED TO BE A REPLICA OF THE CLINICAL CONDITION). IT IS POSSIBLE FOR BIPOLAR INSTRUMENTS TO SPARK AT THE INSTRUMENT CLEVIS WHEN IN A HIGHLY ELECTROLYTIC ENVIRONMENT, SUCH AS WHAT WAS SEEN DURING THE EVENTS OF THIS PCR. UM-001-00046.013 IFU BIPOLAR SURGICAL INSTRUMENTS SPECIFIES TO 'ASPIRATE FLUID FROM THE AREA BEFORE ACTIVATING THE INSTRUMENT. CONDUCTIVE FLUIDS (FOR EXAMPLE, BLOOD OR SALINE) IN DIRECT CONTACT WITH OR IN CLOSE PROXIMITY TO AN ACTIVE ELECTRODE MAY CARRY ELECTRICAL CURRENT OR HEAT AWAY FROM TARGET TISSUES, WHICH MAY CAUSE UNINTENDED BURNS TO THE PATIENT.' IT REMAINS UNCLEAR IF THE BISSINGER BIPOLAR CABLES HAVE AN EFFECT ON THE TESTING, AND THE TECHNICAL DATASHEETS DO NOT HIGHLIGHT ANY DIFFERENCE. THEREFORE, CABLE INCOMPATIBILITY CANNOT BE EXCLUDED. THE ROOT CAUSE IS NOT CONFIRMED. THE EVENT WILL BE TRACKED AND TRENDED. THE HEALTH HAZARD EVALUATION CONFIRMED THAT UNEXPECTED ENERGY DELIVERY BY AN ENERGIZED INSTRUMENT CAN CAUSE OCCULT INTRAABDOMINAL INJURIES, AS THE CURRENT FOLLOWS THE PATH OF LEAST RESISTANCE. IN THIS CASE, THE ISSUE OCCURRED DURING SIMULATION TRAINING AND NO PATIENT WAS PRESENT. THE ROOT CAUSE WAS NOT IDENTIFIED BUT THE FAILURE MODALITY REPLICATED. THIS RISK CAN BE MITIGATED THROUGH CAREFUL INSPECTION OF INSULATION PRIOR TO THE PROCEDURE. THE RISK OF SERIOUS INJURY OR SERIOUS DETERIORATION IN A PATIENT'S STATE OF HEALTH IS APPROPRIATELY CAPTURED FOR THIS SPECIFIC OCCURRENCE WITHIN THE ABOVE THE RISK DOCUMENTATION AS 'SERIOUS'. THE EVENT WAS ADDRESSED IN THE RISK MANAGEMENT FILE OF THE DEVICE AND THE CLINICAL RISK HAS BEEN CONFIRMED TO BE A "LOW" HEALTH RISK. THEREFORE, NO FURTHER ACTIONS ARE REQUIRED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1740642 SENHANCE X0007309, BIPOLAR MARYLAND DISSECTOR Ø 3 MM X 280 MM NAY ASENSUS SURGICAL, INC. X0007309 723504 00815440021634

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown