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	Detachment of Device or Device Component (2907); Device Damaged by Another Device (2915); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
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.

• 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: 24591844
• Report Number: 3007593944-2026-00001
• Device Sequence Number: 8933523
• Product Code: NAY
• UDI-Device Identifier: 00815440021894
• UDI-Public: (01)00815440021894(11)210927(10)139730
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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
• Report Date (Section B): 03/12/2026

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
• Device Model Number: X0007177
• Device Lot Number: 139730
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/16/2026
• Initial Report FDA Received Date: 03/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2021
• 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 Sex: Unknown