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

Model Number 400272

Device Problems Thermal Decomposition of Device (1071); Detachment Of Device Component (1104); Fire (1245); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/14/2017

Event Type  malfunction  

Event Description

Harmonic ace curved shears incert , ref# (b)(4), lot: m10170717, exp: 07/31/2019.A warning came across the harmonic machine that said release pressure on jaws then the jaws started on fire and burned on half of the jaws.The jaws where not in connection to any tissue at the time of event and the jaws were open.Essentially there was no pressure on the jaws.Instrument was removed from the pt as well as the jaw piece that burned off.Packaging and pieces retained and given to manager.Ultimately there was no patient harm.

• Brand Name: ENDOWRIST
• Type of Device: SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.; 1266 kifer road; sunnyvale CA 94086
• MDR Report Key: 7266311
• MDR Text Key: 99948391
• Report Number: 7266311
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874111086
• UDI-Public: (01)00886874111086
• 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: 01/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 07/31/2019
• Device Model Number: 400272
• Device Catalogue Number: 400272
• Device Lot Number: M10170717
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/15/2018
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 01/15/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 80