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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DAVINCI SI SURGEON SIDE CONSOLE

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INTUITIVE SURGICAL, INC DAVINCI SI SURGEON SIDE CONSOLE Back to Search Results
Model Number 380610-21
Device Problem Poor Quality Image (1408)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/25/2020
Event Type  malfunction  
Manufacturer Narrative
Intuitive surgical, inc. (isi) followed up with the fse and obtained the following additional information: no errors occurred during system power up, system functionality, and vision was checked after power up. The fse confirmed no errors occurred in the log files and full troubleshooting was completed. After docking, the surgeon immediately found the right eye was black with no errors; however, the surgeon went into following mode with only left eye vision. Since the right monitor did no function, 2d vision was not available. No patient injury was reported. The hrsv has not been returned to isi for evaluation. The root cause of the customer reported failure mode cannot be determined. A follow-up mdr will be submitted if the instrument is returned (post engineering evaluation) or if additional information is received. Based on the information provided at this time, this complaint is being reported because system unavailability after start of a surgical procedure (first port incision) contributed to the procedure being aborted. Although no patient harm occurred, if this malfunction were to recur it could potentially cause or contribute to an adverse event.
 
Event Description
It was reported that during an unspecified da vinci-assisted prostatectomy surgical procedure, the surgeon side console (ssc) right eye was black right after docking the patient side cart to the patient. A field service engineer (fse) was able to isolate the issue to the ssc right monitor. The surgeon made the decision to abort the procedure post anesthesia and port placement with no reported injury.
 
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Brand NameDAVINCI SI
Type of DeviceSURGEON SIDE CONSOLE
Manufacturer (Section D)
INTUITIVE SURGICAL, INC
3410 central expressway
santa clara CA 95051
Manufacturer (Section G)
INTUITIVE SURGICAL, INC
3410 central expressway
santa clara CA 95051
Manufacturer Contact
david wang
3410 central expressway
santa clara, CA 95051
4085232100
MDR Report Key10547927
MDR Text Key207405068
Report Number2955842-2020-10921
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeSG
PMA/PMN Number
K081137
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation Non-Healthcare Professional
Remedial Action Other
Type of Report Initial,Followup
Report Date 08/25/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/17/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number380610-21
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/21/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/28/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/16/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 09/17/2020 Patient Sequence Number: 1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES
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