BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENHANCE SURGICAL SYSTEM

    MDR report key: 23612530 · Received November 20, 2025

    Report

    Report Number
    3007593944-2025-00003
    Event Type
    Malfunction
    Date Received
    November 20, 2025
    Date of Event
    November 5, 2025
    Report Date
    December 30, 2025
    Manufacturer
    ASENSUS SURGICAL, INC.
    Product Code
    NAY
    UDI-DI
    00815440021894
    PMA / PMN Number
    K171120
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RO
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOWING THE NOTIFICATION OF THE MONOPOLAR L-HOOK INSTRUMENT MALFUNCTION, THE SHIPMENT OF THE FAULTY DEVICE WAS ORGANIZED IN ORDER TO COMMENCE THE INVESTIGATION AS SOON AS POSSIBLE. THE INSTRUMENT WAS SUBSEQUENTLY SENT TO ASENSUS SURGICAL INC. (US HEADQUARTER) TO BE INSPECTED BY THE SUSTAINING TEAM. VISUAL INSPECTION CONFIRMED THE ABSENCE OF A PORTION OF THE CERAMIC INSULATION NEAR THE TIP AND SHOWED THAT THE DISTAL SECTION OF THE CERAMIC WAS LOOSE AND ABLE TO SLIDE ALONG THE INNER SHAFT. ELECTRICAL CONDUCTIVITY WAS DETECTED ON THE MISSING INSULATION PART. UNDER NORMAL CONDITIONS, THE CERAMIC MATERIAL SERVES AS AN INSULATOR. HOWEVER, AS A PORTION OF THE CERAMIC WAS MISSING, THE UNDERLYING METAL ELECTRODE WAS EXPOSED, CONFIRMING THE POSSIBILITY OF BURNING OR DAMAGE TO ANY SUBSTRATE COMING INTO CONTACT WITH IT. THE HOOK WAS NOTICED TO BE SLIGHTLY BENT. THE DEFORMATION SUGGESTED THAT THE HOOK MAY HAVE BEEN SUBJECTED TO EXCESSIVE FORCE OR IMPROPER HANDLING. THE BENDING COULD BE A CONTRIBUTING FACTOR TO THE CERAMIC BREAKAGE, AS CERAMIC MATERIALS ARE BRITTLE AND PRONE TO CRACKING WHEN STRESSED. CONCERNING USE LIFE OF THE PRODUCT, THE CUSTOMER ESTIMATED AROUND 25 USAGES. BASED ON THESE FINDINGS, THE EVALUATION IDENTIFIES THE MOST LIKELY ROOT CAUSE AS MECHANICAL STRESS RESULTING FROM EXCESSIVE FORCE APPLIED TO THE INSTRUMENT TIP, LEADING TO CERAMIC FRACTURE AND EXPOSURE OF THE ELECTRODE. THE OBSERVED TIP DEFORMATION (BENDING) IS CONSISTENT WITH THE APPLICATION OF EXCESSIVE FORCE, AND THE BRITTLE NATURE OF CERAMIC COMPONENTS MAKES THEM SUSCEPTIBLE TO CRACKING UNDER SUCH STRESS. IN CONCLUSION, THE ROOT CAUSE OF THE INSTRUMENT MALFUNCTION WAS MOST LIKELY CAUSED BY EXCESSIVE FORCE, AS THE TIP WAS FOUND TO BE BENT. SUBSEQUENTLY, THE BENDING OF THE TIP COULD HAVE BEEN A FACTOR IN THE CERAMIC BREAKAGE AND DEVIATION FROM ITS ORIGINAL DESIGN.

    Description of Event or Problem · 0

    DATE OF INCIDENT: (B)(6) 2025. LOCATION: (B)(6). DEVICE: MONOPOLAR L-HOOK INSTRUMENT (X0007177). NO INJURY OCCURRED TO A PATIENT OR USER. DURING A PEDIATRIC SURGICAL PROCEDURE INVOLVING A 15-YEAR-OLD PATIENT AT (B)(6) HOSPITAL (B)(6), 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 RISK OF UNINTENDED ENERGY TRANSFER REMAINS A POSSIBILITY THAT REQUIRES VERIFICATION THROUGH THE ONGOING INVESTIGATION. THE SURGICAL TEAM SUCCESSFULLY AND SAFELY REMOVED THE BROKEN INSTRUMENT WITHOUT LEAVING ANY FRAGMENTS INSIDE THE PATIENT, REPLACED IT, AND COMPLETED THE PROCEDURE WITHOUT DELAY OR REPORTED IMPACT. 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 UNINTENDED ENERGY TRANSFER OR SPARKING. THE INTIAL MDR WAS SUBMITTED TO THE FDA ON 20-NOV-2025.

    Description of Event or Problem · 0

    DATE OF INCIDENT: ON (B)(6) 2025. LOCATION: (B)(6). DEVICE: MONOPOLAR L-HOOK INSTRUMENT (X0007177). NO INJURY OCCURRED TO A PATIENT OR USER. DURING A PEDIATRIC SURGICAL PROCEDURE INVOLVING A 15-YEAR-OLD PATIENT AT (B)(6), 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 RISK OF UNINTENDED ENERGY TRANSFER REMAINS A POSSIBILITY THAT REQUIRES VERIFICATION THROUGH THE ONGOING INVESTIGATION. THE SURGICAL TEAM SUCCESSFULLY AND SAFELY REMOVED THE BROKEN INSTRUMENT WITHOUT LEAVING ANY FRAGMENTS INSIDE THE PATIENT, REPLACED IT, AND COMPLETED THE PROCEDURE WITHOUT DELAY OR REPORTED IMPACT. 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 UNINTENDED ENERGY TRANSFER OR SPARKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2441635 SENHANCE SURGICAL SYSTEM X0007177, MONOPOLAR L-HOOK ELECTRODE, 5 MM X 310 MM NAY ASENSUS SURGICAL, INC. X0007177 223110 00815440021894

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Unknown