MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. SINGLE-SITE SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT

Model Number 478090

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/17/2022

Event Type  malfunction  

Event Description

Cautery would not cauterize/cut through intra-abdominal fat.

• Brand Name: SINGLE-SITE
• Type of Device: SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.; 1266 kifer road; sunnyvale CA 94086
• MDR Report Key: 13659181
• MDR Text Key: 286525938
• Report Number: 13659181
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility

Reporter Occupation

• Type of Report: Initial
• Report Date: 02/18/2022

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 03/03/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 478090
• Device Lot Number: N102008030059
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/18/2022
• Event Location: Hospital
• Date Report to Manufacturer: 03/03/2022
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown