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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DAVINCI XI SURGEON SIDE CONSOLE, SMART PEDALS

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INTUITIVE SURGICAL, INC DAVINCI XI SURGEON SIDE CONSOLE, SMART PEDALS Back to Search Results
Model Number 380677-06
Device Problems Poor Quality Image (1408); Defective Component (2292)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/12/2018
Event Type  malfunction  
Manufacturer Narrative
The 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 the reported malfunction were to recur, it could cause or it could cause or contribute to an adverse event.
 
Event Description
It was reported during a da vinci-assisted total hysterectomy procedure, there was no video in the left eye of the surgeon side console (ssc) or the vision tower. The intuitive surgical, inc. (isi) technical support engineer (tse) noted that the customer had swapped endoscopes with no resolution. The tse then had the customer reseat the camera cable and complete a power cycle but the reported issue could not be resolved. At that time, the surgeon made the decision to convert and complete the procedure using traditional laparoscopic techniques. There was no report of patient harm, adverse outcome or injury. An isi field service engineer (fse) was dispatched to the customer site to further investigate the reported complaint. The fse checked the vision on the ssc with color bars and scope imaging. The left eye was completely blacked out. The fse performed troubleshooting by swapping the hrsv monitor left/right cables to see if the issue would follow the wiring. The blacked out image did not follow. The fse then replaced the left hrsv monitor and the issue was resolved. The high resolution stereo viewer is located on the surgeon side console and provides the 3d image captured from the endoscope inserted in the patient.
 
Manufacturer Narrative
Intuitive surgical, inc. (isi) received the high resolution stereo viewer (hrsv) monitor associated with this complaint and completed the device evaluation. Failure analysis confirmed the reported issue ¿ no video for left eye. The printed circuit assembly (pca) main board on the unit was replaced to address the reported issue.
 
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Brand NameDAVINCI XI
Type of DeviceSURGEON SIDE CONSOLE, SMART PEDALS
Manufacturer (Section D)
INTUITIVE SURGICAL, INC
950 kifer rd.
sunnyvale CA 94086
MDR Report Key7932356
MDR Text Key122643105
Report Number2955842-2018-10567
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
PMA/PMN Number
K131861
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 09/12/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/03/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number380677-06
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/18/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/05/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 10/03/2018 Patient Sequence Number: 1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES
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