MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. ENDOWRIST - VESSEL SEALER EXTEND; SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT

Model Number 480422

Device Problem Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/16/2018

Event Type  malfunction  

Event Description

Instrument engage failure.Locks on to tissue, but would not release, the pa had to manually make it release.No harm to patient.

• Brand Name: ENDOWRIST - VESSEL SEALER EXTEND
• Type of Device: SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.; 1266 kifer rd; sunnyvale CA 94086
• MDR Report Key: 8132613
• MDR Text Key: 129320000
• Report Number: 8132613
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874115664
• UDI-Public: (01)00886874115664
• 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: 11/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 480422
• Device Catalogue Number: 480422-01
• Device Lot Number: M10181008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/28/2018
• Event Location: Hospital
• Date Report to Manufacturer: 12/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1