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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 Problem Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/28/2017
Event Type  malfunction  
Manufacturer Narrative
Intuitive surgical, inc. (isi) has received the illuminator involved with this complaint and completed investigation. Failure analysis investigation confirmed the reported failure. The illuminator was installed into the system and failed with no power.
 
Manufacturer Narrative
Intuitive surgical, inc. (isi) has not received the unit for failure analysis. Therefore, the root cause of the customer reported failure mode has not been determined. A follow-up mdr will be submitted if the product is returned and evaluated and/ or 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 prostatectomy procedure, the fuses in the illuminator broke. Another illuminator unit was used to complete the procedure. There was no report of patient harm, adverse outcome or injury. Intuitive surgical, inc. (isi) followed up with the initial reporter and obtained the following additional information: an external illuminator was used to complete the procedure. The procedure was extended 45 minutes and additional anesthesia was administered. There was no report of intra-operative complications. An isi field service engineer (fse) was dispatched to the facility. To resolve the issue the fse replaced the illuminator. The illuminator is a component of the da vinci system that contains a high intensity light source to illuminate the surgical site.
 
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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 Key7148258
MDR Text Key250276902
Report Number2955842-2017-00873
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeNO
PMA/PMN Number
K081137
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/05/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/27/2017
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 Manufacturer01/05/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/11/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/01/2009
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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