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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DAVINCI XI PATIENT SIDE CART, 4-ARM

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INTUITIVE SURGICAL, INC DAVINCI XI PATIENT SIDE CART, 4-ARM Back to Search Results
Model Number 380652-37
Device Problems Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/31/2018
Event Type  malfunction  
Manufacturer Narrative
An isi field service engineer (fse) investigated the reported event. No parts were replaced, a recalibration of the sus resolved the issue. 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 at the start of a da vinci-assisted surgical procedure, the customer experienced system errors 23008. The errors were pointing to the set up structure (sus) column z axis. The intuitive surgical, inc. (isi) technical support engineer (tse) instructed the customer to power down the system, emergency power off, and turned the breakers on and off, however, the issue persisted. At that time, the surgeon made the decision to convert and complete the procedure as an open traditional procedure. 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 confirm the reported failure. The fse recalibrated the sus and tested the system. There was no part replaced, the recalibration of the sus resolved the issue. The sus is the set up system used to position the cluster of usms and their sujs.
 
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Brand NameDAVINCI XI
Type of DevicePATIENT SIDE CART, 4-ARM
Manufacturer (Section D)
INTUITIVE SURGICAL, INC
950 kifer rd.
sunnyvale
Manufacturer (Section G)
INTUITIVE SURGICAL, INC
950 kifer rd.
sunnyvale
Manufacturer Contact
tabitha reed
950 kifer rd.
sunnyvale 
4085232100
MDR Report Key7616467
MDR Text Key112038795
Report Number2955842-2018-10300
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K131861
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 05/31/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/19/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number380652-37
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/31/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/23/2016
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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