MAUDE Adverse Event Report: INTUITIVE SURGICAL INC DAVINCI ENDOSCOPE; SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT

Model Number 370893-03

Device Problem Poor Quality Image (1408)

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

Event Date 04/26/2017

Event Type  malfunction  

Event Description

During robotic prostatectomy, 3-d image on surgeons' consoles became blurry.Different scopes from the same case were tried to correct the problem without success.Then a new robotic camera was tried without success.As a last resort, the scopes for the next case were opened.This solved the problem and the surgery continued with fully functioning equipment.

• Brand Name: DAVINCI ENDOSCOPE
• Type of Device: SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL INC; 1266 kifer rd.; sunnyvale CA 94086
• MDR Report Key: 6544310
• MDR Text Key: 74436997
• Report Number: 6544310
• 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: 04/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 370893-03
• Device Catalogue Number: 370893-03
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/27/2017
• Event Location: Hospital
• Date Report to Manufacturer: 04/27/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 68 YR