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

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

Patient Problem Dysphagia/ Odynophagia (1815)

Event Date 02/10/2022

Event Type  Injury  

Event Description

The complainant, dr.(b)(6) , reported patient had hypotensive esophageal motility with residual pressure at 37mmhg and nicotine abuse, and patient complains of dysphagia post-op.Standard treatment with prednisolone 100mg for 3 days was given, after which the patient was symptom-free.It was reported that causality to the senhance surgical system was probable.On (b)(6) 2022, patient again complains of dysphagia, nicotine abstinence was recommended.In (b)(6) 2022, gastroscopy was performed with functional spasm, achalasia and exclusion of recurrent hernia with balloon dilatation.On (b)(6) 2022, patient was re-operated via laparoscopy with adhesiolysis and repositioning of the stomach in the abdomen for resolution.This event did not occur within the united states.The event occurred at (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 patient experienced dysphagia and was treated with a balloon dilatation procedure.The patient was re-operated with laparoscopy resolving the adverse event on (b)(6) 2022.This event did not occur within the united states.This event occurred at (b)(6) germany.The event occurred on (b)(6) 2022, and asensus surgical was made aware on 01-december-2022.According to the investigation, further responses from surgeon interviews indicated that the dysphagia event was not related to the senhance surgical system, but rather considered to be a normal surgical complication, unrelated to the robot.Additionally, the surgeon confirmed the initial patient id was erroneously reported in the patient id database and the correct patient id is (b)(6).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 ((b)(4)) 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, dr.(b)(6) , reported patient had hypotensive esophageal motility with residual pressure at 37mmhg and nicotine abuse, and patient complains of dysphagia post-op.Standard treatment with prednisolone 100mg for 3 days was given, after which the patient was symptom-free.It was reported that causality to the senhance surgical system was probable.On (b)(6) 2022, patient again complains of dysphagia, nicotine abstinence was recommended.In (b)(6) 2022, gastroscopy was performed with functional spasm, achalasia and exclusion of recurrent hernia with balloon dilatation.On (b)(6) 2022, patient was re-operated via laparoscopy with adhesiolysis and repositioning of the stomach in the abdomen for resolution.This event did not occur within the united states.The event occurred at (b)(6) in germany.Additionally, this event occurred on (b)(6) 2022, and asensus surgical was internally made aware on 01-december-2022.

• Brand Name: SENHANCE
• Type of Device: SENHANCE SUGICAL 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; milano, lombardy 20126 ; IT 20126
• Manufacturer Contact: casey hinckley ; 1 tw alexander dr; suite 160; durham, NC 27703-7035 ; 9197658400
• MDR Report Key: 17774529
• MDR Text Key: 323743213
• Report Number: 3007593944-2023-00010
• 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: 10/13/2023

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: 12/01/2022
• Initial Date FDA Received: 09/19/2023
• Supplement Dates Manufacturer Received: 12/01/2022
• 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