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 Rectal Anastomotic Leakage (4482)

Event Date 10/20/2020

Event Type  Injury  

Event Description

The complainant, (b)(6), reported that on day 6, there was an anastomotic leakage detected, then clinically and digitally confirmed.Patient was administered antibiotic therapy (metronidazole-500 mg 3x daily; cefuroxime-1 g 3x daily) and had a prolonged hospital stay but recovered for a (b)(6) 2020 date of resolution.It was reported that causality to the senhance surgical system was possible.This event did not occur within the u.S.This event occurred in (b)(6) hospital in lithuania.Additionally, this event occurred on (b)(6) 2020, and asensus surgical was internally made aware on 10-august-2023.

Event Description

The complainant, (b)(6), reported that on day 6, there was an anastomotic leakage detected, then clinically and digitally confirmed.Patient was administered antibiotic therapy (metronidazole-500 mg 3x daily; cefuroxime-1 g 3x daily) and had a prolonged hospital stay but recovered for a 04-november-2020 date of resolution.It was reported that causality to the senhance surgical system was possible.This event did not occur within the u.S.This event occurred in (b)(6) hospital in lithuania.Additionally, this event occurred on 20-october-2020, and asensus surgical was internally made aware on 10-august-2023.

Manufacturer Narrative

Based on the complaint details ((b)(4)), the patient experienced anastomotic leakage, was successfully treated with antibiotics (metronidazole 500mg 3x daily, cefuroxime 1g 3x daily), and had a prolonged hospital stay but recovered for a 04-november-2020 date of resolution.This event did not occur within the united states.This event occurred at (b)(6) hospital in lithuania.The event occurred on 20-october-2020, and asensus surgical was made aware on 10-august-2023.According to the investigation, further responses from surgeon interviews indicated that the anastomotic leakage 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 (b)(4) 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: 17774502
• MDR Text Key: 323743073
• Report Number: 3007593944-2023-00004
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: LH
• 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: 08/10/2023
• Initial Date FDA Received: 09/19/2023
• Supplement Dates Manufacturer Received: 08/10/2023
• Supplement Dates FDA Received: 10/12/2023
• 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): Hospitalization; Required Intervention