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

Catalog Number 410322

Device Problems Device Operates Differently Than Expected (2913); Mechanical Jam (2983)

Patient Problem No Information (3190)

Event Date 11/20/2015

Event Type  malfunction  

Event Description

Endo wrist one vessel sealer #410322; lot m10150728 faulted during a procedure.Blade jammed while attempting to seal thin tissue (tube).Non recoverable fault alarmed, alarm reset, instrument unplugged; re-plugged into unit, 2nd fault alarm, instrument replaced.

• Brand Name: ENDOWRIST ONE VESSEL SEALER
• Type of Device: SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.; 1266 kifer rd; sunnyvale, CA 94086
• MDR Report Key: 5273138
• MDR Text Key: 32874272
• Report Number: 5273138
• 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: 11/24/2015

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: Physician
• Device Catalogue Number: 410322
• Device Lot Number: M10150728
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/24/2015
• Event Location: Hospital
• Date Report to Manufacturer: 11/24/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/08/2015
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 47 YR