MAUDE Adverse Event Report: ASENSUS SURGICAL, INC. SENHANCE; SENHANCE SURGICAL SYSTEM

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Dysphagia/ Odynophagia (1815)

Event Date 09/05/2022

Event Type  Injury  

Event Description

The complainant, dr.(b)(6), reported that on (b)(6) 2022, a gastroscopy was performed for dysphagia.This event revealed a bolus occlusion in the lower esophagus with necrosis of the wall to indicate an esophageal perforation.The patient was treated via re-laparoscopy, esophageal suture, esosponge, and several vac changes.Vac therapy was completed on (b)(6) 2022.On (b)(6) 2022, an x-ray swallow showed tightness and after a slow build-up of food, the patient was discharged on (b)(6) 2022.At home the patient was listless and was re-admitted as inpatient from (b)(6) 2022 thru (b)(6) 2022 when she was discharged.After this period, patient did well with no weight loss and no dysphagia.It was reported that causality to the senhance surgical system was certain.This event did not occur within the united states.The event occurred in (b)(6).Additionally, this event occurred on (b)(6) 2022, and asensus surgical was internally made aware on 02-december-2022.

Event Description

The complainant, dr.(b)(6) reported that on (b)(6) 2022, a gastroscopy was performed for dysphagia.This event revealed a bolus occlusion in the lower esophagus with necrosis of the wall to indicate an esophageal perforation.The patient was treated via re-laparoscopy, esophageal suture, esosponge, and several vac changes.Vac therapy was completed on (b)(6) 2022 on (b)(6) 2022, an x-ray swallow showed tightness and after a slow build-up of food, the patient was discharged on (b)(6) 2022.At home the patient was listless and was re-admitted as inpatient from (b)(6) 2022 thru (b)(6) 2022 when she was discharged.After this period, patient did well with no weight loss and no dysphagia.It was reported that causality to the senhance surgical system was certain.This event did not occur within the united states.The event occurred in (b)(6).Additionally, this event occurred on (b)(6) 2022, and asensus surgical was internally made aware on 02-december- 2022.

Manufacturer Narrative

Based on the complaint details, there was a report of an adverse event to a patient.This event did not occur within the u.S.This event occurred at (b)(6).The event occurred on (b)(6) 2022, and asensus surgical was internally made aware on 02-dec-2022.According to the investigation, further responses from the surgeon confirmed that the problem was associated with the medical history of the patient and not related the senhance surgical system.No causality with the senhance surgical system was identified.Furthermore, no malfunction of the senhance system was reported.No failures were identified.The risk posed by this event was evaluated though hhe-001-00034 and a corrective action preventative action plan (capa-000048) has been opened to manage the unsuitable timeliness of the receipt and management of this reported event.

• Brand Name: SENHANCE
• Type of Device: SENHANCE SURGICAL SYSTEM
• Manufacturer (Section D): ASENSUS SURGICAL, INC.; 1 tw alexander drive; 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 drive; durham, NC 27703-7035 ; 9197658400
• MDR Report Key: 17774590
• MDR Text Key: 323744578
• Report Number: 3007593944-2023-00009
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K171120
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/12/2023

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/02/2022
• Initial Date FDA Received: 09/19/2023
• Supplement Dates Manufacturer Received: 12/02/2022
• Supplement Dates FDA Received: 10/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Female