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U.S. Department of Health and Human Services

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

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INTUITIVE SURGICAL, INC DAVINCI XI PATIENT SIDE CART, 4-ARM Back to Search Results
Model Number 380652-22
Device Problem Physical Resistance/Sticking (4012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/17/2022
Event Type  malfunction  
Event Description
It was reported that during a da vinci-assisted partial nephrectomy surgical procedure that there was excess friction on arm 1. The clinical sales rep (csr) stated that the friction feeling was intermittent and mostly was noticed when the surgeon was reaching forward, but not so much when moving backwards or other directions. The csr stated that the customer replaced the trocar, instrument, and reseated the drape, but with no resolution to the issue. The technical support engineer (tse) reviewed the system error logs and noticed a single 282 instrument tool sensor detection error reporting by universal surgical manipulator (usm) 1. The tse informed the csr that the instrument wasn't being fully sensed by arm 1 at some point, so if the issue persisted after replacing the instrument, trocar, and reseating the drape, then the tse recommended the customer replace the drape on arm 1 to see if the issues persisted. The tse recommended the csr ensure that the drape material was not too tight or pulling tightly when the surgeon moved arm 1. The csr stated that the customer decided to move arm 1 out of the way and use arms 2, 3, and 4 to continue on with the procedure. The tse recommended for the csr to obtain the drape lot # and work with the customer to return the suspected drape. The csr stated that the surgeon has had this same issue occur two or three times in different procedures with arm 1. The surgeon requested for the field service engineer (fse) to inspect the system and resolve issue as soon as possible. The procedure was completed with no reports of patient injury. Intuitive surgical inc (isi) followed up with the initial reporter and obtained the following additional information: it is unknown if the system initially powered on without errors or if there was any external interference with the arms.
 
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 replaced universal surgical manipulator 1 (usm1) due to the carriage locking in place at the bottom of the guide rail near the cannula mount, in accordance with isi procedures. The system was tested and verified as ready for use. Isi received the part(s) involved with this complaint and completed the device evaluation. Failure analysis confirmed and reproduced the customer's reported complaint. The unit was tested on an in house system and passed normal mode. The unit passed the following tests: lissajous, sensors check, and sine cycle. The usm failed the insertion friction very slow, speed low, and speed high tests. The insertion motor rotor and gearbox will be replaced as a fix. A review of the site's complaint history does not show any additional complaints related to this product and/or this event. There were no images or procedure videos provided for review. This complaint is reportable due to the following: a usm was abandoned after the start of the procedure and the surgeon was able to continue with the procedure robotically using 3 arms. 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 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 conversion/abortion.
 
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Brand NameDAVINCI XI
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 Key13832834
MDR Text Key297153072
Report Number2955842-2022-10682
Device Sequence Number1
Product Code NAY
UDI-Device Identifier00886874110720
UDI-Public(01)00886874110720
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,Company Representative
Reporter Occupation Non-Healthcare Professional
Remedial Action Other
Type of Report Initial
Report Date 02/17/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/20/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number380652-22
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/21/2022
Date Manufacturer Received02/17/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/04/2014
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: 03/20/2022 Patient Sequence Number: 1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES
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