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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DAVINCI SI; VISION SIDE SYSTEM, RECERTIFIED
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INTUITIVE SURGICAL, INC DAVINCI SI; VISION SIDE SYSTEM, RECERTIFIED Back to Search Results
Model Number 380690-03
Device Problems Electrical /Electronic Property Problem (1198); Defective Component (2292); Device Displays Incorrect Message (2591)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/12/2019
Event Type  malfunction  
Manufacturer Narrative
Isi has received the illuminator involved with this complaint and completed the device evaluation.Failure analysis confirmed the customer reported complaint.The illuminator was installed into pca system and it failed to power on with error 48238.A follow-up mdr will be submitted 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, the illuminator stopped working and the system faulted.The intuitive surgical, inc.(isi) technical support engineer (tse) had provided troubleshooting steps; however, the issue persisted.The site completed the procedure robotically with an external illuminator.There was no report of patient harm, adverse outcome or injury.An isi field service engineer (fes) was dispatched to the facility and was able to reproduce the reported failure.The fse replaced the illuminator to resolve the issue.The illuminator contains a high-intensity light source to illuminate the surgical site and the electronics for initial processing of endoscopic video.
 
Manufacturer Narrative
During additional failure analysis, the reported failure was confirmed.Auxiliary board in power supply failed.Power supply needs to be replaced.Lamp spring bracket is missing and will be replaced.
 
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Brand Name
DAVINCI SI
Type of Device
VISION SIDE SYSTEM, RECERTIFIED
Manufacturer (Section D)
INTUITIVE SURGICAL, INC
950 kifer rd.
sunnyvale CA 94086
MDR Report Key8489751
MDR Text Key141369106
Report Number2955842-2019-10260
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 distributor,foreign
Type of Report Initial,Followup
Report Date 03/12/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/06/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number380690-03
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/26/2019
Date Manufacturer Received09/25/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES
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