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

Model Number 410322

Device Problem Retraction Problem (1536)

Patient Problem No Information (3190)

Event Date 03/05/2018

Event Type  malfunction  

Event Description

Recoverable fault for vessel sealer.It had been working properly and then the blade would not retract back.Fault #32001.Called support line and talked to manufacturer's representative.

• Brand Name: ENDOWRIST;DAVINCI SI
• Type of Device: SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.; 1266 kifer road; sunnyvale CA 94086
• MDR Report Key: 7530041
• MDR Text Key: 108783263
• Report Number: 7530041
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Unknown
• Device Expiration Date: 12/31/2019
• Device Model Number: 410322
• Device Catalogue Number: 410322
• Device Lot Number: M11180103
• Other Device ID Number: 410322-05
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/11/2018
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 05/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO; NO OTHER THERAPIES
• Patient Age: 45 YR