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 Problems Vomiting (2144); Stenosis of the esophagus (4487)

Event Date 05/28/2022

Event Type  Injury  

Event Description

The complainant, (b)(6) , reported that a patient experienced narrow stenosis in the gastro-esophageal area and vomiting for which treatment with antiemetics was administrated (domperidone-50,00 mg total dosage); additionally, an ogd + dilatation was performed for a (b)(6) 2022 date of resolution.It was reported that causality to the senhance surgical system was possible.This event did not occur within the united states.The event occurred in (b)(6) in germany.Additionally, this event occurred on (b)(6) 2022, and asensus surgical was internally made aware on (b)(6) 2022.

Manufacturer Narrative

Based on the complaint details ( (b)(4) ), the female patient experienced narrow stenosis in the gastro-esophageal area and associated vomiting for which patient was treated with antiemetics (domperidone; total dosage administrated: 50,00 mg) and performed an ogd (oesophagogastroduodenoscopy) with dilatation for a (b)(6) 2022 date of resolution.This event did not occur within the united states.This event occurred at evangelisches krankenhaus wesel in germany.The event occurred on 28-may-2022, and asensus surgical was made aware on 04-july-2022.According to the investigation, further responses from surgeon interviews indicated that the adverse event was not related to the senhance surgical system, but rather considered to be a normal surgical complication unrelated to the robot.Furthermore, no malfunction of the senhance system was reported and no failures were identified.The risk posed by this event was evaluated through a health hazard evaluation (hhe-001-00031) 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.Therefore, asensus surgical is reporting this followup for completeness to the initial mdr report submitted on 19-september-2023.

Event Description

The complainant, (b)(6), reported that a patient experienced narrow stenosis in the gastro-esophageal area and vomiting for which treatment with antiemetics was administrated (domperidone-50,00 mg total dosage); additionally, an ogd + dilatation was performed for a (b)(6) 2022 date of resolution.It was reported that causality to the senhance surgical system was possible.This event did not occur within the united states.The event occurred in evangelisches krankenhaus wesel gmbh in germany.Additionally, this event occurred on 28-may-2022, and asensus surgical was internally made aware on 04-july-2022.

• Brand Name: SENHANCE
• Type of Device: SENHANCE SURGICAL SYSTEM
• 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: 17774536
• MDR Text Key: 323743548
• Report Number: 3007593944-2023-00015
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K171120
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• 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: 06/29/2022
• Initial Date FDA Received: 09/19/2023
• Supplement Dates Manufacturer Received: 06/29/2022
• 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
• Patient Sex: Female