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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DAVINCI SI VISION SIDE SYSTEM

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INTUITIVE SURGICAL, INC DAVINCI SI VISION SIDE SYSTEM Back to Search Results
Model Number 380990-08
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 05/22/2018
Event Type  malfunction  
Manufacturer Narrative
An isi field service engineer (fse) was dispatched to the facility and was able to reproduce the reported complaint. Fse performed white balance with white paper and the white balance passed. The light also turned to a normal white light output with no issues noted. The fse instructed the customer to only use white paper to white balance. No further issues noted. No parts were replaced. The illuminator is a component of the da vinci system that contains a high intensity light source to illuminate the surgical site. The 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 the reported malfunctioned were to recur it could cause or contribute to an adverse event.
 
Event Description
It was reported that prior to the start of a da vinci-assisted total benign hysterectomy procedure, the light was blue and customer could not white balance scope. The intuitive surgical, inc. (isi) technical support engineer (tse) instructed the customer to power down the system and cycle the vision side cart breaker. The system powered back on, but the blue light remained and the customer was unable to white balance. The tse instructed the customer to use a third party light source to continue with the procedure. There was no report of patient harm, adverse outcome or injury. Isi made multiple follow up attempts and obtained the following additional information: the clinical sales representative (csr) stated anesthesia was given to the patient but couldn't confirm if any port incisions had been made on the patient at the time the issue occurred.
 
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Brand NameDAVINCI SI
Type of DeviceVISION SIDE SYSTEM
Manufacturer (Section D)
INTUITIVE SURGICAL, INC
950 kifer rd.
sunnyvale
Manufacturer (Section G)
INTUITIVE SURGICAL, INC
950 kifer rd.
sunnyvale
Manufacturer Contact
tabitha reed
950 kifer rd.
sunnyvale 
4085232100
MDR Report Key7607123
MDR Text Key112150811
Report Number2955842-2018-10293
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 05/22/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/15/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number380990-08
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/22/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/16/2011
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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