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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 A60P9B
Device Problems Poor Quality Image (1408); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/25/2017
Event Type  malfunction  
Manufacturer Narrative
Intuitive surgical inc. (isi) received the unit involved with this complaint and completed the device evaluation. Failure analysis confirmed the customer reported failure. During the video test there was right image loss. The issue was caused by the right camera control unit (ccu). 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 total benign hysterectomy procedure, there was vision loss in the right eye. The intuitive surgical, inc. (isi) technical support engineer (tse) advised the customer to ensure the cable connections were tight and perform a system restart with breaker reset; however, the issue persisted. The tse reviewed the logs and found an error 48232 pointing to the dual camera controller unit (doco). The tse had the customer remove the camera cable from the doco, power system up and install a new camera cable. The error 48232 recurred. The surgeon made the decision to convert and complete the procedure as a traditional open surgical procedure. There was no patient harm, adverse outcome or injury reported. An isi field service engineer (fse) was dispatched to the facility and replaced the doco to resolve the issue. The doco is located on the vsc and it receives and processes video signals.
 
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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 Key6861529
MDR Text Key86133616
Report Number2955842-2017-00595
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 health professional
Reporter Occupation
Type of Report Initial
Report Date 08/25/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/13/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberIS3000 A60P9B
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/05/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/25/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/01/2009
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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