MAUDE Adverse Event Report: ASENSUS SURGICAL, INC. SENHANCE SURGICAL SYSTEM; X0007177, MONOPOLAR L-HOOK ELECTRODE, 5 MM X 310 MM

Model Number	X0007177
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261); Naturally Worn (2988)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
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.
Additional Manufacturer Narrative
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.
Event or Problem Description
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.

• Brand Name: SENHANCE SURGICAL SYSTEM
• Common Device Name: X0007177, MONOPOLAR L-HOOK ELECTRODE, 5 MM X 310 MM
• Manufacturer (Section D): ASENSUS SURGICAL, INC.; 1 tw alexander dr; suite 160; durham NC 27703 7035
• Manufacturer (Section G): ASENSUS SURGICAL ITALIA, S.R.L; viale dell'innovazione, 3; milan, lombardy 20126 ; IT 20126
• Manufacturer Contact: casey hinckley ; 1 tw alexander dr; suite 160; durham, NC 27703-7035 ; 9197658400
• MDR Report Key: 23612530
• Report Number: 3007593944-2025-00003
• Device Sequence Number: 9711911
• Product Code: NAY
• UDI-Device Identifier: 00815440021894
• UDI-Public: (01)00815440021894(11)220608(10)223110
• Combination Product (Y/N): N
• Initial Reporter Country: RO
• PMA/510(K) Number: K171120
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/30/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: X0007177
• Device Lot Number: 223110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2025
• Supplement Date Received by Manufacturer: 11/06/2025
• Initial Report FDA Received Date: 11/20/2025
• Supplement Report FDA Received Date: 12/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/08/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 15 YR
• Patient Sex: Unknown