BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENHANCE

    MDR report key: 20904574 · Received December 11, 2024

    Report

    Report Number
    3007593944-2024-00002
    Event Type
    Malfunction
    Date Received
    December 11, 2024
    Date of Event
    November 29, 2024
    Report Date
    January 17, 2025
    Manufacturer
    ASENSUS SURGICAL, INC.
    Product Code
    NAY
    UDI-DI
    00815440020224
    PMA / PMN Number
    K171120
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NO INJURY OCCURRED TO A PATIENT OR USER. ACCORDING TO THE INVESTIGATION, THE INSTRUMENT USAGE WAS ESTIMATED AROUND 100 USES AND WENT THROUGH MORE STERILE PROCESSING CYCLE AS PART OF A LARGER TRAY GIVEN THE 600+ PROCEDURES PERFORMED BY THE SITE. THE SCRUB TECH DID NOT COMMENT ON INSTRUMENT BEFORE/DURING SETUP OF CASE, IT WAS VISUALIZED DURING PROCEDURE, RECORDING OF VIDEO SHOWED IT WAS ALREADY DAMAGED WHEN IT ENTERED THE FIELD. THE INSTRUMENT WAS CONFIRMED TO HAVE BEEN DISPOSED OF. GIVEN THE ESTIMATED USAGES AND ABOVE MENTIONED CONSIDERATIONS, THE ROOT CAUSE OF THE ISSUE CAN BE POSSIBLY ATTRIBUTED TO THE WEAR AND TEAR OF THE DEVICE OCCURRING AS A RESULT OF INSTRUMENT HANDLING/USAGE OVER TIME. HOWEVER, AS THE INSTRUMENT IS NOT AVAILABLE FOR FURTHER INVESTIGATION, IT IS NOT POSSIBLE TO REPLICATE THE FAILURE MODALITY AND CONFIRM THE ROOT CAUSE. A DEDICATED HEALTH HAZARD EVALUATION (HHE-001-00050) WAS DEVELOPED TO ASSESS THE RISK POSED BY THE UNINTENDED ENERGY CONDUCTION. THE RISK OF SERIOUS INJURY OR SERIOUS DETERIORATION IN A PATIENT'S STATE OF HEALTH IS ADEQUATELY CAPTURED WITHIN THE RISK DOCUMENTATION AS 'SERIOUS'. THE CLINICAL RISK POSED BY THE EVENT HAS BEEN CONFIRMED TO BE A 'LOW' HEALTH RISK. THESE ADDITIONAL DETAILS ARE BEING REPORTED TO FDA FOR (US) FOLLOWUP TO THE INITIAL REPORT SUBMITTED ON 11-DEC-2024.

    Description of Event or Problem · 0

    NO INJURY OCCURRED TO A PATIENT OR USER. THE EVENT OCCURRED AT (B)(6) IN THE UNITED STATES ON 29-NOV-2024, AND ASENSUS SURGICAL WAS ALSO MADE AWARE ON 29-NOV-2024. THERE WAS A <15 MINUTE DELAY TO THE SURGICAL CASE WITH NO IMPACT TO THE PATIENT, AND THE SURGEON CONVERTED TO TRADITIONAL LAPAROSCOPY TO COMPLETE THE CASE. THE EVENT INFORMATION STATES THAT DURING A SECOND PROCEDURE USING THE SYSTEM ON THIS DATE, THE SURGEON OBSERVED THAT A MONOPOLAR L-HOOK ELECTRODE WAS CONDUCTING ENERGY FROM A SMALL SPOT ON THE SHAFT OF THE INSTRUMENT JUST ABOVE THE TIP. THE INSTRUMENT APPEARED TO BE "ARCHING" ENERGY. THE SURGEON NOTICED A BRIGHT, FLASH-LIKE SPOT ABOUT AN INCH ABOVE THE TIP OF THE INSTRUMENT AS THE INSTRUMENT TOUCHED AN AREA OF FAT NEAR THE GALLBLADDER WHICH PROMPTED THE TEAM TO FURTHER INSPECT THE INSTRUMENT. THE INSTRUMENT WAS INSPECTED AND THE SHAFT COATING WAS NOTICED TO BE PHYSICALLY DAMAGED. NO HARM OR INJURY TO THE PATIENT OCCURRED AS A RESULT OF THIS AND THE INSTRUMENT WAS DEEMED UNUSABLE, AND THE REMAINDER OF THE CASE WAS COMPLETED WITH TRADITIONAL LAPAROSCOPY.

    Description of Event or Problem · 0

    NO INJURY OCCURRED TO A PATIENT OR USER. THE EVENT OCCURRED AT (B)(6) MEDICAL CENTER AT (B)(6) IN THE UNITED STATES ON (B)(6) 2024, AND ASENSUS SURGICAL WAS ALSO MADE AWARE ON 29-NOV-2024. THERE WAS A <15 MINUTE DELAY TO THE SURGICAL CASE WITH NO IMPACT TO THE PATIENT, AND THE SURGEON CONVERTED TO TRADITIONAL LAPAROSCOPY TO COMPLETE THE CASE. THE EVENT INFORMATION STATES THAT DURING A SECOND PROCEDURE USING THE SYSTEM ON THIS DATE, THE SURGEON OBSERVED THAT A MONOPOLAR L-HOOK ELECTRODE WAS CONDUCTING ENERGY FROM A SMALL SPOT ON THE SHAFT OF THE INSTRUMENT JUST ABOVE THE TIP. THE INSTRUMENT APPEARED TO BE "ARCHING" ENERGY. THE SURGEON NOTICED A BRIGHT, FLASH-LIKE SPOT ABOUT AN INCH ABOVE THE TIP OF THE INSTRUMENT AS THE INSTRUMENT TOUCHED AN AREA OF FAT NEAR THE GALLBLADDER WHICH PROMPTED THE TEAM TO FURTHER INSPECT THE INSTRUMENT. THE INSTRUMENT WAS INSPECTED AND THE SHAFT COATING WAS NOTICED TO BE PHYSICALLY DAMAGED. NO HARM OR INJURY TO THE PATIENT OCCURRED AS A RESULT OF THIS AND THE INSTRUMENT WAS DEEMED UNUSABLE, AND THE REMAINDER OF THE CASE WAS COMPLETED WITH TRADITIONAL LAPAROSCOPY. THIS INITIAL REPORT WILL BE CONFIRMED OR REEVALUATED BASED ON THE INVESTIGATION RESULTS, AT WHICH TIME ASENSUS WILL SEND A FOLLOW-UP MDR REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2495004 SENHANCE X0007035, MONOPOLAR L-HOOK ELECTRODE, 5 MM X 310 MM NAY ASENSUS SURGICAL, INC. X0007035 1733307 00815440020224

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown