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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DAVINCI SI VISION SIDE SYSTEM

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INTUITIVE SURGICAL, INC DAVINCI SI VISION SIDE SYSTEM Back to Search Results
Model Number 380990-03
Device Problems Defective Component (2292); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913); Power Problem (3010)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/04/2018
Event Type  malfunction  
Manufacturer Narrative
The unit has been returned to isi for failure analysis evaluation. Failure analysis confirmed that the illuminator would not ignite. The unit was installed on an in-house pca system did not ignite with in-house lamp module upon startup and system error code # 48245 was generated. This complaint is being reported due to a da vinci surgical 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 cholecystectomy procedure, a possible "spark" or "flash" was observed near the illuminator cord connection. The customer stated that a smell of smoke was then noted at the time the incident occurred. At that time, the surgeon made the decision to complete the procedure using traditional laparoscopic techniques. There was no report of any patient harm, adverse outcome or injury. An intuitive surgical, inc. (isi) field service engineer (fse) was dispatched to the site. The fse found no evidence of smoke, fire or melted materials associated with the da vinci surgical system. Review of the site's system log for the reported procedure date found multiple occurrences of system error code # 48244. The fse concluded that the system error code 48244 was associated with the illuminator. To resolve the issue, the fse replaced the illuminator. The illuminator provides the light which is transported to the system endoscope and projected onto the surgical site.
 
Manufacturer Narrative
Additional failure analysis investigations found that the illuminator's power supply failed, thus causing the customer reported issue.
 
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Brand NameDAVINCI SI
Type of DeviceVISION SIDE SYSTEM
Manufacturer (Section D)
INTUITIVE SURGICAL, INC
950 kifer rd.
sunnyvale
MDR Report Key7643249
MDR Text Key112566833
Report Number2955842-2018-10324
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
PMA/PMN Number
K081137
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial,Followup
Report Date 06/04/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/27/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number380990-03
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/11/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/08/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 06/27/2018 Patient Sequence Number: 1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES
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