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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 A60P9B IS3000
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 10/25/2017
Event Type  malfunction  
Manufacturer Narrative
Isi received the unit involved with this complaint and completed the device evaluation. Failure analysis was not able to reproduce the customer reported failure; however, it was confirmed via the error logs. Visual inspection was performed. The arm was installed onto the system and it powered up. A sine cycle and a test drive were performed without any issues. Tests performed via matlab passed. 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 hysterectomy procedure, recoverable faults occurred while the system was sitting idle. The intuitive surgical, inc. (isi) technical support engineer (tse) reviewed the system logs and found errors 25596 and 30 pointing to armnet 3 communication issue. There was no report of patient harm, adverse outcome or injury. Isi followed up with the initial reporter and obtained the following additional information: the procedure was aborted post anesthesia and port placement due to the re-occurring faults that would not recover. An isi field service engineer (fse) was dispatched to the facility and was able to reproduce the reported problem. The fse replaced the endoscopic camera manipulator (ecm) to resolve the issue. The ecm is the camera arm located on the patient side cart (psc) which provides the sterile interface for the 3d endoscope.
 
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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 Key7007621
MDR Text Key92215229
Report Number2955842-2017-00756
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 other
Reporter Occupation
Type of Report Initial
Report Date 10/25/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/07/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberA60P9B IS3000
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/25/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/01/2010
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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