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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 380677-13
Device Problem Failure to Sense (1559)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/10/2022
Event Type  malfunction  
Event Description
It was reported that during a da vinci-assisted prostatectomy surgical procedure, the customer called an intuitive surgical, inc. (isi) technical support engineer (tse) and reported that one of the surgeon side consoles (ssc) was having issues with the finger clutch not working. The customer moved to the other ssc and proceeded with the case as planned with no report of patient injury.
 
Manufacturer Narrative
An isi field service engineer (fse) was dispatched to the customer site to further investigate the reported complaint. Fse tested the system in normal mode and no errors were found. Fse completed a test drive of the ssc with a simulator and no problems were found on the mtm clutches. The fse verified both sscs were working per isi procedures and no part replacement was required. Following service, the system was tested and verified as ready for use. The cause of the reported issue at the time of the event remains unknown. A review of the site's complaint history does not reveal any additional complaints involving this product and/or this event. No image or procedure video was provided. A review of the site's system logs for the reported procedure date was conducted by rpms analyst. Investigation revealed there were no related system errors to have occurred during the surgical procedure that would have likely caused or contributed to the reported complaint. This complaint is considered a reportable event due to the following conclusion: system unavailability after the 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 convert or abort. 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. If additional information becomes available, the complaint will be re-evaluated.
 
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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 Key13502253
MDR Text Key287534032
Report Number2955842-2022-10213
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
Remedial Action Other
Type of Report Initial
Report Date 01/10/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/09/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number380677-13
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/10/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/13/2018
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: 02/09/2022 Patient Sequence Number: 1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES
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