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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 Problem Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/31/2017
Event Type  malfunction  
Manufacturer Narrative
Intuitive surgical, inc. (isi) has received the touch screen computer involved with this complaint and completed the device evaluation. Failure analysis investigation confirmed the reported failure. Visual inspection was performed and a flat cable was found touching the sheet metal. The part was installed to pca system and at startup, the touchpad was blank and an error 75 popped up.
 
Manufacturer Narrative
Isi has not received the unit involved with this complaint, therefore, the root cause of the customer reported failure mode cannot be determined. 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 myomectomy procedure, the second surgeon side console (ssc) froze. The customer was informed by the intuitive surgical, inc. (isi) technical support engineer (tse) that it could be due to an error 75. The customer still had one hour remaining for the case. The procedure was completed using the first ssc. 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 reproduce the problem. The fse replaced the touch screen to resolve the issue.
 
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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 Key7058281
MDR Text Key256525474
Report Number2955842-2017-00793
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,Followup
Report Date 10/31/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/26/2017
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? Device Returned to Manufacturer
Date Returned to Manufacturer11/28/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/06/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/01/2010
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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