BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENHANCE SURGICAL SYSTEM

    MDR report key: 24591844 · Received March 13, 2026

    Report

    Report Number
    3007593944-2026-00001
    Event Type
    Malfunction
    Date Received
    March 13, 2026
    Date of Event
    February 16, 2026
    Report Date
    March 12, 2026
    Manufacturer
    ASENSUS SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00815440021894
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DAMAGED INSTRUMENT HAS BEEN DISCARDED BY THE CUSTOMER AND IS THUS NOT AVAILABLE FOR INVESTIGATION ON THE PRODUCT. HOWEVER, A THE REVIEW OF THE LOG HISTORY FILES AND SURGICAL FOOTAGE REVEALED NO RELEVANT FINDINGS OR IRREGULARITIES. EXCEEDING FORCES WERE DETECTED, BUT NOT SIGNIFICANTLY HIGHER THAN THE 20N THRESHOLD ALLOWED DURING TELEOPERATION AND THUS SUFFICIENT TO INDUCE SUCH AN EVIDENT DEVICE BREAKAGE. A MONOPOLAR L-HOOK ELECTRODE Ø 5 MM X 310 MM PN X0007177, LOT 139/730 (SAME LOT AS THE INSTRUMENT OBJECT OF THIS COMPLAINT) WAS STILL AVAILABLE AT ASENSUS SURGICAL ITALIA DEMO ROOM AS A NOT FOR HUMAN USE (NFHU) DEVICE. THUS, A TEST WAS PERFORMED TO MEASURE THE FORCES WITHSTOOD BY THE INSTRUMENT. A FORCE GAUGE WAS USED TO DETECT FORCES APPLIED TO THE INSTRUMENT IN ALL DIRECTIONS. AS THE LOG FILES IDENTIFIED THAT THE FULCRUM WAS SET AT 40 CM, THE FULCRUM WAS THEREFORE SET AT THE SAME DISTANCE. SUBSEQUENTLY, FORCES UP TO 32 N WERE APPLIED ON THE FULCRUM IN ALL DIRECTIONS. THE DEVICE WITHSTOOD THE APPLIED STRESS, AND NO BREAKAGE OCCURRED; NEITHER A SIGN OF DETERIORATION NOR EARLY DETACHMENT WAS VISIBLE. THUS, A MANUFACTURING DEFECT ASSOCIATED WITH THE LOT 139/730 OBJECT OF THIS COMPLAINT CAN BE CONSIDERED UNLIKELY. IN CONCLUSION, THE INSTRUMENT WAS DISCARDED THE ROOT CAUSE CANNOT BE CONFIRMED. A MANUFACTURING DEFECT CANNOT BE RULED OUT AS A POTENTIAL ROOT CAUSE. HOWEVER, IN VIEW OF THE TEST RESULTS OBTAINED ON THE NFHU DEVICE, AND THE DHR REVIEW FINDINGS, IT IS DEEMED UNLIKELY TO BE A CONTRIBUTING FACTOR. A POTENTIAL CONTRIBUTION FROM RELEVANT WEAR AND TEAR DUE TO INSTRUMENT COLLISIONS BEING REPORTED, AND DEVICE USAGE NEEDS TO BE TAKEN INTO ACCOUNT.

    Description of Event or Problem · 0

    DATE OF INCIDENT: (B)(6) LOCATION: (B)(6), AUSTRIA DEVICE: MONOPOLAR L-HOOK INSTRUMENT (X0007177) NO ADVERSE EVENT OCCURRED TO A PATIENT OR USER. DURING A PEDIATRIC SURGICAL PROCEDURE INVOLVING A PEDIATRIC PATIENT (MALE, 172CM, 80KG) AT (B)(6), AUSTRIA, WHERE THE SENHANCE SURGICAL SYSTEM IS INSTALLED, THE 5 MM MONOPOLAR L-HOOK INSTRUMENT BROKE AT ITS DISTAL PART. THIS TYPE OF BREAKAGE IS CONSIDERED POTENTIALLY CRITICAL BECAUSE THE DISTAL PORTION OF THE INSTRUMENT IS RESPONSIBLE FOR TRANSMITTING ELECTRICAL ENERGY. BASED ON THE ONLY IMAGE OF THE DAMAGED INSTRUMENT, ITS CONDITION HAD THE POTENTIAL TO LEAD TO UNINTENDED ENERGY DISCHARGE OR SPARKING. HOWEVER, ACCORDING TO THE REPORT RECEIVED, NO ENERGY DISPERSION AND NO TISSUE DAMAGE WAS OBSERVED OR REPORTED DURING THE EVENT. THE INSTRUMENT DID NOT FALL INTO THE PATIENT. AND COMPLETED THE PROCEDURE WITHOUT DELAY OR REPORTED IMPACT BY TRANFERING TO TRADITIONAL LAPAROSCOPY. NO HARM OCCURRED AND NO ENERGY DISPERSION WAS REPORTED, HOWEVER IF THIS INCIDENT WERE TO RECUR THEN THE INSTRUMENT BREAKAGE HAS THE POTENTIAL TO CAUSE TISSUE DAMAGE DUE TO IF THE INSTRUMENT SLIPPED INTO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    558324 SENHANCE SURGICAL SYSTEM X0007177, MONOPOLAR L-HOOK ELECTRODE, 5 MM X 310 MM NAY ASENSUS SURGICAL, INC X0007177 139730 00815440021894

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown