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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 380451-06
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 02/28/2018
Event Type  malfunction  
Manufacturer Narrative
Intuitive surgical, inc.Received the unit involved with this complaint and completed the device evaluation.Failure analysis was able to reproduce the customer reported complaint.The bottom of the axis 4 gear clamp has dropped below the mid-point of the housing boss.The axis 4 gear clamp will be reinstalled properly and the gear clamp screw will be replaced.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, errors occurred on the right master tool manipulator (mtm) indicating a homing failure.The procedure was converted to laparoscopic surgery with no reported injury.Intuitive surgical, inc.(isi) followed up with the reporter and obtained additional information about the complaint.The customer called tech support and troubleshooting was performed by a reboot and power cycle of the system.However, the issue was unresolved.An isi field service engineer (fse) was dispatched to the customer site to further investigate the reported complaint.The reported complaint was confirmed based on the field evaluation.The field service engineer (fse) resolved the issue by replacing the mtm.The mtm refers to the master controllers which provide the means for the surgeon to control the instruments and endoscope inside the patient from the surgeon side console (ssc).One mtm is assigned to the surgeon's left hand (mtml) and one to the right (mtmr).
 
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Brand Name
DAVINCI SI
Type of Device
SURGEON SIDE CONSOLE
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 Key7366719
MDR Text Key103669202
Report Number2955842-2018-10096
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeTW
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Reporter Occupation Other
Type of Report Initial
Report Date 02/28/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number380451-06
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/21/2018
Initial Date Manufacturer Received 02/28/2018
Initial Date FDA Received03/23/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/11/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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