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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 A70.P7B
Device Problems Bent (1059); Poor Quality Image (1408); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/15/2017
Event Type  malfunction  
Manufacturer Narrative
The doco was returned for evaluation. Failure analysis confirmed the customer reported complaint. Visual inspection found that the center pin of the right camera control unit (ccu) was bent. The right ccu will be replace to repair the doco. 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, the surgeon experienced video loss in the right eye of the high resolution stereo (hrsv) viewer after replacing the illuminator. The customer checked to ensure that the camera cable was secure, performed a cycle power of the system, and replaced the camera head; however, the issue persisted. Due to the reported vision issue, the surgeon made the decision to complete the planned surgical procedure using traditional laparoscopic techniques. There was no report of patient harm, adverse outcome or injury. An intuitive surgical, inc. (isi) field service engineer (fse) was dispatched to the facility and was able to reproduce the customer reported complaint. The fse found that the center pin in the right eye video connection of the double camera controller (doco) was bent. The fse replaced the doco to resolve the reported vision loss 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 Key7108830
MDR Text Key95742170
Report Number2955842-2017-00833
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 11/15/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/12/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberIS3000 A70.P7B
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 Received11/15/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/01/2009
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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