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

Model Number	X0007177
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Perforation of Esophagus (2399)
Date of Event	12/18/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The surgeon and the complainant reported that the issue was not related to the use of the senhance system used in the first procedure performed but rather induced by electrocautery.The only energy powered asensus surgical device used was a monopolar l-hook electrode ø 5 mm x 310 mm pn x0007177 lot number 929721.A service history review on the senhance system and a device history review on the monopolar hook were completed.No similar occurrences or anomalous findings were identified.As reported in notes of the complaint details section, the surgeon was deemed to be too close to the vessels.No malfunction of any device was reported.According to the surgeon, it could just as easily have occurred during open or laparoscopic surgery.Dr.(b)(6), medical affairs and professional education, commented that a gastric perforation along the greater curvature is a known complication of fundoplication as a result of thermal spread to gastric tissue during short gastric vessel sealing.Regardless of the type of device used to seal these vessels, care must be taken by the operator to not get too close to the stomach during sealing and to limit the deployment of energy to short bursts.These types of maneuvers can help to limit lateral thermal spread and decrease the incidence of perforation.Perforations of the stomach in this operation are a known complication with varying etiologies.There is no report or indication that any asensus surgical's device failed to meet specifications.An health hazard evaluation (tracked as (b)(4)) was initiated.As this is the first case where a perforation of the wrap after a fundoplication occurred, the event will be tracked and trended.
Event or Problem Description
The event was made aware on 12/19/2023.The event occurred at (b)(6).As initially reported by the complainant, on thursday, (b)(6) 2022, doctor visschers, performed a fundoplication on a pediatric female patient.The patient was doing well and was discharged on friday, (b)(6) 2022.No change to the surgical approach or additional ports were needed.On sunday, (b)(6) 2022 the patient was readmitted to the hospital with persistent abdominal pain, which required a second operation.The surgeons diagnosed a perforation of the wrap, surrounding the esophagus, deemed to be related to a thermal lesion affecting the vasa previa, namely the branches of splenic artery and vein that run to the greater curvature of the stomach.The patient was therefore treated with antibiotics and 2 drains were applied on the stomach and small pelvis.Subsequent echography and gastroscopy revealed no indication of a persistent perforation.On friday,(b)(6) 2022 the patient was doing well and was reported to be lively and active.The surgeon and the complainant reported that the issue was not related to the use of the senhance system used in the first procedure performed but rather induced by electrocautery.The instruments that apply energy used during the robotic assisted fundoplication were a monopolar l-hook electrode ø 5 mm x 310 mm (x0007177) and a bipolar maryland dissector ø 5 mm x 310 mm (x0005149).The surgeon was deemed to be too close to the vessels.No malfunction of any device was reported.Also according to the investigation, there is no indication that any asensus surgical's device failed to meet specifications.

• Brand Name: SENHANCE
• Common Device Name: MONOPOLAR L-HOOK ELECTRODE Ø 5 MM X 310 MM
• Manufacturer (Section D): ASENSUS SURGICAL, INC.; 1 tw alexander drive; suite 160; durham NC 27703
• 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 drive; durham, NC 27703
• MDR Report Key: 16113208
• Report Number: 3007593944-2023-00001
• Device Sequence Number: 12479535
• Product Code: NAY
• UDI-Device Identifier: 00815440021894
• UDI-Public: 00815440021894
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 01/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: X0007177
• Device Catalogue Number: X0007177
• Device Lot Number: 929721
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2022
• Initial Report FDA Received Date: 01/06/2023
• Was Device Evaluated by Manufacturer? (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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 3 YR
• Patient Sex: Female