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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 A60P3
Device Problems Electrical /Electronic Property Problem (1198); Poor Quality Image (1408)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/01/2017
Event Type  malfunction  
Manufacturer Narrative
Intuitive surgical, inc. (isi) received the high resolution stereo view (hrsv-3) lcd monitor associated with this complaint and completed the device evaluation. Failure analysis confirmed the reported event. Investigation found that the hrsv-3 lcd monitor would not turn on. This report does not admit that the report or information submitted under this report constitutes an admission that the device, intuitive surgical or intuitive surgical employees, caused or contributed to the reportable event.
 
Manufacturer Narrative
Intuitive surgical, inc. (isi) received the part involved with this complaint. However, the failure analysis investigation is still in progress and therefore the root cause of the customer reported failure has not been determined. A follow up mdr will be submitted once the investigation has been completed and/or if additional information is received. 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 that during a da vinci-assisted surgical procedure, as the customer docked to the patient and the surgeon sat at the surgeon side console (ssc), no video in the left eye was noted. The customer attempted troubleshooting by power cycling two times with a breaker reset and by unplugging all video connections to the personality module surgeon console (pmsc). The intuitive surgical inc. (isi) technical support engineer (tse) had the customer move the blue cable and perform another breaker reset, however, the issue persisted. At that time, the surgeon made the decision to abort the robotic procedure and reschedule for a later date. There was no report of patient harm, adverse outcome or injury. An isi field service engineer (fse) was dispatched to the facility and was able to reproduce the vision problem. The fse replaced the left high resolution stereo viewer (hrsv) monitor on the ssc to resolve the issue.
 
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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 Key6601196
MDR Text Key195844989
Report Number2955842-2017-00343
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,Followup
Report Date 05/01/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/31/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberIS3000 A60P3
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/18/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/27/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/01/2009
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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