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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DAVINCI XI SURGEON SIDE CONSOLE, SMART PEDALS

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INTUITIVE SURGICAL, INC DAVINCI XI SURGEON SIDE CONSOLE, SMART PEDALS Back to Search Results
Model Number 380677-23
Device Problem Failure to Sense (1559)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/08/2021
Event Type  malfunction  
Manufacturer Narrative
An intuitive surgical, inc. (isi) field service engineer (fse) was dispatched to the customer site to further investigate the reported complaint. The fse was able to replicate the reported complaint. The master tool manipulator (mtm) could not be opened all the way. The fse noted the springs on the mtm were worn out and replaced the mtm to resolve the reported issue. The system was tested and verified as ready for use. Isi received the mtm involved with this complaint and completed the device evaluation. Failure analysis investigation reproduced the grip calibration failure along axis 8/gimbal grip during visual inspection. The root cause was determined to be a component failure. The following parts will be replaced as a fix: grip lever, inner grip spring, and outer grip spring. A review of the site's complaint history does not reveal any additional complaints involving this product and/or this event. No image from the reported event was provided for review. A log review was unable to be performed due to incomplete procedure information being available. This complaint is considered a reportable malfunction due to the following conclusion: system unavailability after start of a surgical procedure could lead to the procedure to be converted/aborted and may lead to an injury due to the patient¿s inability to tolerate a conversion/abortion. While there was no harm or injury to the patient, the reported failure mode could likely cause or contribute to an adverse event if it were to recur.
 
Event Description
It was reported that during a da vinci-assisted prostatectomy surgical procedure, the surgeon was unable to match grips on the surgeon side console (ssc) in order to take control of the instruments. Intuitive surgical, inc. (isi) technical support engineer (tse) recommended power cycling the system and/or move to a second ssc. The surgeon elected to use the second ssc without completing any troubleshooting with the tse. Isi followed up with the initial reporter (clinical sales representative) and confirmed that the procedure was completed using the second ssc with no injury to the patient.
 
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Brand NameDAVINCI XI
Type of DeviceSURGEON SIDE CONSOLE, SMART PEDALS
Manufacturer (Section D)
INTUITIVE SURGICAL, INC
3410 central expressway
santa clara CA
Manufacturer (Section G)
INTUITIVE SURGICAL, INC
3410 central expressway
santa clara CA
Manufacturer Contact
izabel nielson
3410 central expressway
santa clara, CA 
4085232100
MDR Report Key13138829
MDR Text Key289452086
Report Number2955842-2021-11848
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K131861
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional
Reporter Occupation Non-Healthcare Professional
Remedial Action Other
Type of Report Initial
Report Date 12/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/02/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number380677-23
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/17/2021
Date Manufacturer Received12/08/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/01/2021
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: 01/02/2022 Patient Sequence Number: 1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES
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