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

Model Number	X0007177
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2025
Type of Reportable Event	Malfunction
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.It was reported that during a robotically-assisted laparoscopic cholecystectomy procedure, a material separation occurred involving a monopolar l-hook instrument.While the robotic surgical system was maneuvering the instrument to facilitate continued dissection of the gallbladder from the liver bed, the l-hook detached from the adapter and descended into the patient's abdomen without direct surgeon command.Subsequent bedside examination revealed that the l-hook had separated from the adapter while the adapter remained affixed to the manipulator arm.The detached l-hook was observed suspended within the trocar until manually and fully retrieved by the bedside assistant.Examination of the abdominal cavity indicated no apparent contact between the detached l-hook and any anatomical structures.The surgical procedure experienced a delay of less than 15 minutes as a result of this event.The attending surgeon reported no concerns regarding potential tissue injury related to the device malfunction.An investigation into the cause of the material separation was completed.Immediate disposal prevented extensive device investigation and lot number confirmation.However, the investigation that was completed revealed that the sales support representative confirmed proper l-hook assembly under asensus employee supervision, functioning for 20 minutes before spontaneous disassembly.The representative noted the instrument's age and heavy use, suspecting a broken plastic sheath securing the fastening cap led to shaft breakage, instability, increased force on the metal cylinder interface, and subsequent instrument slippage once the cylinder detached.The product ifu indicates that senhance passive/monopolar instrument lifespan depends on wear/damage from use/handling and should be inspected prior to use.This inspection requirement must verify proper function, straightness, jaw alignment, insulation integrity, and absence of damage.Given this information, the root cause is unconfirmed.Potential contributing factors include device wear and tear, overuse, and weld failure at the metal cylinder-shaft connection (due to wear), leading to shaft breakage and disassembly.This event, being the first recorded instance at the site of an instrument shaft detachment from an adapter during a surgical case, will be tracked and trended for analysis.

• Brand Name: SENHANCE
• 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: 21987574
• Report Number: 3007593944-2025-00001
• Device Sequence Number: 8553164
• Product Code: NAY
• UDI-Device Identifier: 00815440021894
• UDI-Public: (01)00815440021894(11)210927(10)139730
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• 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
• Report Date (Section B): 05/08/2025

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: 139730
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2025
• Initial Report FDA Received Date: 05/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown