MAUDE Adverse Event Report: ASENSUS SURGICAL, INC. SENHANCE; X0007309, BIPOLAR MARYLAND DISSECTOR Ø 3 MM X 280 MM

Model Number	X0007309
Medical Device Problem Codes	Break (1069); Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Date of the incident: (b)(6) 2025.Date of awareness: 25-june-2025.Location: (b)(6) hospital, (b)(6).Device name: 3mm bipolar instrument.According to the event information, during the simulation training session, 3mm bipolar instrument was used without any problems.During the simulation training, no issues or malfunctions with the instrument was observed.However, during cleaning, the staff discovered the hinge to be burnt/discolored.The training was performed on a simulated organ model made of a water based gel.The complainant also reported that it was the first use of the instrument, and the esu setting was 30w.Since the issue occurred during training, there was no patient harm or surgical case impact reported.No sparks were identified during the use of the instrument.The investigation of the issue is ongoing.
Event or Problem Description
Date of the incident: (b)(6) 2025.Date of awareness: 25-june-2025.Location: (b)(6) hospital.Device name: 3mm bipolar instrument.According to the event information, during the simulation training session, 3mm bipolar instrument was used without any problems.During the simulation training, no issues or malfunctions with the instrument was observed.However, during cleaning, the staff discovered the hinge to be burnt/discolored.The training was performed on a simulated organ model made of a water based gel.The complainant also reported that it was the first use of the instrument, and the esu setting was 30w.Since the issue occurred during training, there was no patient harm or surgical case impact reported.No sparks were identified during the use of the instrument.The customer used a 80100088 cable (pn x0007819) in conjunction with a bipolar maryland dissector x0007309 with a valleylab ft10 esu.Um-001-00035_us (from which the japanese um is based) refers to cable 80100088 as compatible with only 'bipolar scissors'.Therefore, a potential cable incompatibility has been noticed.The testing team confirmed the presence of sparks at the clevis during the test when the instrument was in contact with the substrate (saline-soaked sponge).Sparks were confirmed on all 3 instruments tested.The testing team suspects that the presence of electrolytic fluid making contact at the clevis of the instrument could have generated the sparks (although in a high electrolytic environment, which is not intended to be a replica of the clinical condition).It is possible for bipolar instruments to spark at the instrument clevis when in a highly electrolytic environment, such as what was seen during the events of this pcr.Um-001-00046.013 ifu bipolar surgical instruments specifies to 'aspirate fluid from the area before activating the instrument.Conductive fluids (for example, blood or saline) in direct contact with or in close proximity to an active electrode may carry electrical current or heat away from target tissues, which may cause unintended burns to the patient.' it remains unclear if the bissinger bipolar cables have an effect on the testing, and the technical datasheets do not highlight any difference.Therefore, cable incompatibility cannot be excluded.The root cause is not confirmed.The event will be tracked and trended.The health hazard evaluation confirmed that unexpected energy delivery by an energized instrument can cause occult intraabdominal injuries, as the current follows the path of least resistance.In this case, the issue occurred during simulation training and no patient was present.The root cause was not identified but the failure modality replicated.This risk can be mitigated through careful inspection of insulation prior to the procedure.The risk of serious injury or serious deterioration in a patient's state of health is appropriately captured for this specific occurrence within the above the risk documentation as 'serious'.The event was addressed in the risk management file of the device and the clinical risk has been confirmed to be a "low" health risk.Therefore, no further actions are required at this time.

• Brand Name: SENHANCE
• Common Device Name: X0007309, BIPOLAR MARYLAND DISSECTOR Ø 3 MM X 280 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 27703-7035 ; 9197658459
• MDR Report Key: 22509316
• Report Number: 3007593944-2025-00002
• Device Sequence Number: 21182964
• Product Code: NAY
• UDI-Device Identifier: 00815440021634
• UDI-Public: (01)00815440021634(11)250120(10)723504
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K183098
• 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): 08/13/2025

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: X0007309
• Device Lot Number: 723504
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2025
• Supplement Date Received by Manufacturer: 06/25/2025
• Initial Report FDA Received Date: 07/15/2025
• Supplement Report FDA Received Date: 08/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown