MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. ENDOWRIST;DAVINCI SI; SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT

Model Number 410322

Device Problems Device Slipped (1584); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/14/2018

Event Type  malfunction  

Event Description

Patient was brought in to surgery for intended procedure; placed in dorsal lithotomy position, prepped and draped in sterile surgical fashion.Per report: sealer malfunctioned--blade came out.On further investigation, malfunction happened outside the patient's body.Vessel sealer changed and procedure continued without further incident.No patient harm done.Manufacturer response for endowrist vessel sealer - intuitive, intuitive (per site reporter).Need to follow-up with surgery inventory coordinator.

• Brand Name: ENDOWRIST;DAVINCI SI
• Type of Device: SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.; 1266 kifer rd; building 101; sunnyvale CA 94086
• MDR Report Key: 8611416
• MDR Text Key: 145086808
• Report Number: 8611416
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/02/2019,05/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 410322
• Device Catalogue Number: 410322
• Device Lot Number: M10180905
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/02/2019
• Event Location: Hospital
• Date Report to Manufacturer: 05/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 29565 DA
• Patient Weight: 62