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 Bowel Burn (1756)

Event Date 08/17/2022

Event Type  Injury  

Event Description

The complainant, prof.(b)(6), reported a transabdominal preperitoneal repair (rtapp) was performed on (b)(6) 2022, and next day the patient was discharged without problems.On (b)(6) 2022 the patient had abdominal pain and inflammation for which an organ lesion was suspected and the patient was re-operated.The re-surgery found a thermic lesion of the small bowel (3cm) with abscess for which an open resection and ileoascendostomy were performed.The patient follow-up was uneventful noting 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 25-september-2022.

Event Description

The complainant, prof.Ludger staib, reported a transabdominal preperitoneal repair (rtapp) was performed on (b)(6) 2022, and next day the patient was discharged without problems.On (b)(6) 2022, the patient had abdominal pain and inflammation for which an organ lesion was suspected and the patient was re-operated.The re-surgery found a thermic lesion of the small bowel (3cm) with abscess for which an open resection and ileoascendostomy were performed.The patient follow-up was uneventful noting 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 klinikum esslingen in germany.Additionally, this event occurred on 17-august-2022, and asensus surgical was internally made aware on 25-september-2022.

Manufacturer Narrative

Based on the complaint details (pcr-001564), the patient was readmitted in the hospital after an rtapp due to abdominal pain and inflammation.An open resection and ileoascendostomy was performed due to a thermic lesion detected on the small bowel with abscess.The patient recovered for a (b)(6) 2022 date of resolution.This event did not occur within the united states.This event occurred at klinikum esslingen in germany.The event occurred on 17-aug-2022, and asensus surgical was made aware on 25-sept-2022.According to the investigation, further responses from surgeon interviews indicated that the severe 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-001-00033) 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.

• 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: 17774580
• MDR Text Key: 323744547
• Report Number: 3007593944-2023-00014
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/13/2023

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 This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention