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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 380652-37
Device Problem Physical Resistance/Sticking (4012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/16/2022
Event Type  malfunction  
Event Description
It was reported that during a da vinci-assisted incisional hernia tapp surgical procedure, the customer encountered an insertion issue on all arms with multiple instruments. The customer disabled the universal surgical manipulator (usm) #1. Intuitive surgical, inc. (isi) technical support engineer (tse) reviewed the logs and noted multiple errors 23068 pointing to usm1 axis 4. The site continued to complete the procedure as planned with no reported patient injury. After the procedure was completed, isi clinical sales representative (csr) performed a hard reset on the system and the error persisted on usm1. Csr performed another reboot on the system, and it powered back on without any errors. Tse recommended disabling usm1 again if the reported error returns. Isi followed up with customer and confirmed that the error did not return during the following procedure. The surgeon was able to complete the subsequent procedure with all arms without any errors.
 
Manufacturer Narrative
An intuitive surgical, inc. (isi) field service engineer (fse) was dispatched to the customer site to further investigate the reported complaint. Fse could not replicated the insertion issues on any arms. Fse replaced universal surgical manipulator (usm) #1 as a precaution. The system was tested and verified as ready for use. Isi received the usm involved with this complaint and completed the device evaluation. Failure analysis investigation confirmed but did not replicate the reported complaint. The unit was tested on an in-house system and passed normal mode. Logs recorded errors 23068 on degree of freedom (dof) #5 repeatedly. When the carriage assembly was inspected, there was no haze/debris on rotor mirrors, or on instrument sterile adapter (isa) windows. Hall sensor flat flex cable (ffc) was fully connected. The unit went through more testing on the test platform and passed carriage lissajous, chipencoder virtual absolute (cva) characterization, brake release, brake hold, sine cycle, friction test, carriage sensors check, carriage friction and advanced brake tests. Isa printed circuit assembly (pca) will be replaced as a fix. A review of the site's system logs for the reported procedure date was conducted by intuitive surgical, inc. (isi) technical support engineer (tse). Investigation revealed the following possible related system errors: 23068 (primary sensor latency error on usm1 axis 4). This complaint is considered a reportable malfunction due to the following conclusion: a usm was disabled 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/aborted and may lead to an injury due to the patient's inability to tolerate a procedure change.
 
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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 Key13816399
MDR Text Key297076427
Report Number2955842-2022-10661
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 02/16/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/18/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number380652-37
Device Catalogue Number380652
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/21/2022
Date Manufacturer Received02/16/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/07/2017
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: 03/18/2022 Patient Sequence Number: 1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES
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