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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL,INC. DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM

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INTUITIVE SURGICAL,INC. DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM Back to Search Results
Model Number IS3000.A60P9B
Device Problem Poor Quality Image (1408)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/02/2017
Event Type  malfunction  
Manufacturer Narrative
The field service engineer (fse) was onsite and spoke to the charge nurse who informed him that the issue was resolved by swapping the vsc to restore the left eye video. The customer will purchase new blue fiber cables. The fse did not replace any parts but did inspect the system, tested and verified it was ready for use. This complaint is being reported due to a da vinci system malfunction rendering the da vinci system unavailable for use after the start of a surgical procedure. Although no patient harm occurred, if this malfunction were to recur it could cause or contribute to an adverse event.
 
Event Description
It was reported during a da vinci-assisted prostatectomy procedure, there was no image in left eye of the surgeon side console (ssc). The intuitive surgical, inc. (isi) technical support engineer (tse) reviewed the system logs and found error 48308 indicating loss of console video from the ssc. The customer reseated the blue fiber cables but the issue persisted. The tse recommended swapping the blue fiber cable and possibly the scc. The customer stated that they swapped the blue fiber cable to the scc and also swapped the vision side cart (vsc). The customer indicated that the issue was resolved swapping out the vsc and the blue fiber cable. There was no report of patient harm, adverse outcome or injury.
 
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Brand NameDA VINCI SI SURGICAL SYSTEM
Type of DeviceENDOSCOPIC INSTRUMENT CONTROL SYSTEM
Manufacturer (Section D)
INTUITIVE SURGICAL,INC.
sunnyvale CA
Manufacturer (Section G)
INTUITIVE SURGICAL, INC.,
950 kifer rd
sunnyvale CA
Manufacturer Contact
tabitha reed
950 kifer rd
sunnyvale, CA 
4085232420
MDR Report Key6984899
MDR Text Key90764585
Report Number2955842-2017-00714
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K081137
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Type of Report Initial
Report Date 10/02/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/27/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberIS3000.A60P9B
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/02/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/01/2009
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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