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 Insufficient Information (4580)

Event Date 10/21/2022

Event Type  Injury  

Event Description

The event occurred outside the united states.The event occurred on (b)(6) 2022, internally made aware on (b)(6) 2023.The patient experienced suture failure which required intervention for treatment (resolved on (b)(6) 2022).Intervention included, relaparoscopy, colonoscopy, and endovac therapy.It was reported that the causality to the senhance surgical system was possible.

Manufacturer Narrative

Based on the complaint details ( (b)(4) ), the patient experienced a suture failure which required an intervention of treatment with a second laparoscopy, colonoscopy, and endovac therapy.This event did not occur within the united states.This event occurred at evangelisches krankenhaus wesel in germany.The event occurred on 21-october-2022, and asensus surgical was made aware on 09-march-2023.According to the investigation, further responses from surgeon interviews indicated that the suture failure event that occurred was not related to the senhance surgical system and possibly with the stapler-anastomosis.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-001-00035) 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 event occurred outside the united states.The event occurred on 10/21/2022, internally made aware on 3/9/2023.The patient experienced suture failure which required intervention for treatment (resolved on (b)(6) 2022).Intervention included, relaparoscopy, colonoscopy, and endovac therapy.It was reported that the causality to the senhance surgical system was possible.

• 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 dr; suite 160; durham, NC 27703-7035 ; 9197658400
• MDR Report Key: 17774611
• MDR Text Key: 323745053
• Report Number: 3007593944-2023-00006
• 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: 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: 03/09/2023
• Initial Date FDA Received: 09/19/2023
• Supplement Dates Manufacturer Received: 03/09/2023
• 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): Required Intervention