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

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.

• Brand Name: DAVINCI XI
• Type of Device: PATIENT 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 Key: 13816399
• MDR Text Key: 297076427
• Report Number: 2955842-2022-10661
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874110720
• UDI-Public: (01)00886874110720
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 380652-37
• Device Catalogue Number: 380652
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2022
• Initial Date Manufacturer Received: 02/16/2022
• Initial Date FDA Received: 03/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/07/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES