MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. XI HARMONIC ACE; SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT

Device Problems Device Stops Intermittently (1599); Device Inoperable (1663)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/02/2016

Event Type  malfunction  

Event Description

The davinci harmonic instrument stopped working mid-dissection of the tissue.The machine was turned off and on but still would not work.It was replaced with a new device to complete the procedure.The patient closed and transported to pacu in stable condition post operation.The disposable device stopped working and a replacement was used to complete the procedure without incidental injury.

• Brand Name: XI HARMONIC ACE
• Type of Device: SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.; 950 kifer rd.; sunnyvale CA 94086
• MDR Report Key: 6442469
• MDR Text Key: 71149935
• Report Number: 6442469
• 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: 03/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Unknown
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/08/2017
• Event Location: Hospital
• Date Report to Manufacturer: 03/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 41 YR