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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 380652-42
Device Problem Physical Resistance/Sticking (4012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/23/2022
Event Type  malfunction  
Event Description
It was reported that during a da vinci-assisted prostatectomy radical w/lymphadenectomy surgical procedure, the customer experienced resistance on universal surgical manipulator (usm) 1 insertion axis after inserting around 2 cm past the cannula tip then the customer experienced heavy resistance on the surgeon side console from the patient side and the surgeon was not able to get to the desired area with the instrument. It was noted that the customer replaced the trocar and reseated the instrument and confirmed there was no drape resistance prior to calling in. The technical support engineer (tse) found no related errors when checking the logs. The customer was unsure if the site had exchanged instruments or reseated the drape however the customer did recall using the needle driver instrument. It was noted that the customer decided to proceed with the case using usm 2 in place of usm 1. The tse advised the customer to power cycle the system and perform a test of the insertion axis to verify if the error was recreated. The tse later confirmed with the customer that the site test drove arm 1 without issues. The procedure was continuing as planned with no reported injury.
 
Manufacturer Narrative
An intuitive surgical, inc. (isi) field service engineer (fse) was dispatched to the customer site to further investigate the reported complaint. The field service engineer (fse) followed up with the customer and identified resistance was felt when moving universal surgical manipulator (usm) 1. The fse resolved the issue after replacing the usm. The system was tested and verified as ready for use. The usm has been received and analyzed by failure analysis. The reported failure was confirmed but not replicated. The unit was tested on an in-house system and passed normal mode. The unit was tested using a drape with a multiple instruments. There was no resistance issue encountered. The unit passed all tests. There was no issue found. A log review was performed and the following was confirmed: two radical prostatectomy with lymphadenectomy procedures were performed (b)(6) 2022. On system sk2034. This complaint is considered a reportable event due to the following conclusion: 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 start of a surgical procedure could lead to the procedure to be converted or aborted and may lead to an injury due to the patient's inability to tolerate a conversion or abortion. Blank mdr fields: device expiration date for section d4 was left blank. Field d6 is blank because the product is not implantable. Field e4 is blank because it is unknown if the initial reporter submitted a report to the fda. Fields g5 and g7 are not applicable.
 
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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 Key14190711
MDR Text Key299005602
Report Number2955842-2022-11192
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,Health Professional
Reporter Occupation
Remedial Action Other
Type of Report Initial
Report Date 03/23/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/22/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number380652-42
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/30/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/23/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/13/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 04/22/2022 Patient Sequence Number: 1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES
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