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U.S. Department of Health and Human Services

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

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INTUITIVE SURGICAL INC DAVINCI ENDOSCOPE SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT Back to Search Results
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.
 
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Brand NameDAVINCI ENDOSCOPE
Type of DeviceSYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT
Manufacturer (Section D)
INTUITIVE SURGICAL INC
1266 kifer rd.
sunnyvale CA 94086
MDR Report Key6544310
MDR Text Key74436997
Report Number6544310
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 04/27/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/04/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number370893-03
Device Catalogue Number370893-03
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/27/2017
Event Location Hospital
Date Report to Manufacturer04/27/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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