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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DAVINCI SI PATIENT SIDE CART, 4-ARM

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INTUITIVE SURGICAL, INC DAVINCI SI PATIENT SIDE CART, 4-ARM Back to Search Results
Model Number 380614-10
Device Problem Use of Device Problem (1670)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/14/2022
Event Type  malfunction  
Event Description
It was reported that during a da vinci-assisted radical prostatectomy without lymphadenectomy surgical procedure, the jaws of the monopolar curved scissors did not always open/close properly. The technical support engineer (tse) viewed the system logs and did not find any error related to the problem. The site used a different instrument. The tse recommended they reseat the sterile adapter/instrument, push the emergency button and recover from the fault, and test the other arm controlled by the same master tool manipulator (mtm). The caller stated they did this and none of the actions worked. The surgeon most likely did not remove the lymph nodes due to the problem. The procedure was completed with no reported injury. Intuitive surgical, inc. (isi) followed up on 16-feb-2022 and 21-feb-2021 obtained the following additional information: sometimes the instrument worked and sometimes it did not. The instrument was not stuck on tissue. A backup instrument was not used. The instrument was inspected prior to use and there was no damage or anything out of the ordinary. No fragment fell into the patient. The monopolar curved scissors (mcs) tip cover was present on the instrument during the procedure. The surgeon performed a limited lymphadenectomy as the surgeon did not trust the mcs for the delicate procedure step. The mcs had a problem opening/closing and did not exactly respond to the surgeon¿s movements. The patient will not be rescheduled for a lymphadenectomy at a later date according to the pathological report. The surgery was completed as planned robotically. The surgeon had the same problem with a backup instrument.
 
Manufacturer Narrative
An isi field service engineer (fse) was dispatched to the customer site to further investigate the reported complaint. There were no problems during tests, but there was a lot of mechanical damage on the outside of the patient side manipulator (psm). The fse replaced the psm. The system was tested and verified as ready for use. Isi received the psm involved with this complaint and completed the device evaluation. Failure analysis investigation was unable to reproduce or confirm the reported failure. Visual inspection was performed. The arm was installed onto the system and powered up. Sine cycle and a test drive were performed without any issues. Tests performed via matlab passed. There was no trouble found. A review of the site's complaint history does not show any additional complaints related to this product and/or this event. No image or procedure video was provided for review. A review of the logs was performed and the procedure date and system information were confirmed. Based on the information provided at this time, this complaint is being reported due to the following conclusion: 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. 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 procedure change.
 
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Brand NameDAVINCI SI
Type of DevicePATIENT SIDE CART, 4-ARM
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 Key13781270
MDR Text Key287263339
Report Number2955842-2022-10630
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeBE
PMA/PMN Number
K081137
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Company Representative
Reporter Occupation Non-Healthcare Professional
Remedial Action Other
Type of Report Initial
Report Date 02/14/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/16/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number380614-10
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/07/2022
Date Manufacturer Received02/14/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/20/2012
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: 03/16/2022 Patient Sequence Number: 1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES
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