MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DAVINCI SI; PATIENT SIDE CART, RECERTIFIED

Model Number	380686-04
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted donor hepatectomy surgical procedure, the surgeon was complaining jerky movement on the patient side manipulator (psm) 1 while insertion movement.The customer checked the drape obstruction, it cleared and swapping instrument in the universal surgical manipulator (usm) 1 with usm 3 also had the same issue for another instrument too.The system was not connected to the onsite, therefore intuitive surgical, inc.(isi) technical support engineer (tse) could not be able to check live logs.The procedure was completed with no reported injury.Isi followed up with the initial reporter and obtained the following additional information: the issue occurred during procedure.
Additional Manufacturer Narrative
Based on the claim against the product by the customer noting psm1 jerk movement, an investigation is in progress to determine the cause of this reported event.Additional information is being gathered to determine the contribution of the device to the customer reported issue."an" isi field service engineer (fse) was dispatched to the customer site to further investigate the reported complaint.The fse replaced the psm 2 to resolve the reported issue.An isi did not receive a da vinci product to perform failure analysis.Therefore, the root cause of the alleged customer reported failure mode has not been determined.The investigation to determine the cause of this reported event is currently in progress.As such, the probable root cause cannot yet be determined based on the information provided.Complaints are tracked via the qms processes.This complaint is considered a reportable malfunction event due to the following conclusion: it was alleged that the psm1 had jerky movement.While there was no harm or injury to the patient, system unavailability after the start of a surgical procedure could likely cause or contribute to an adverse event if it were to recur as it may lead to an injury due to the patient¿s inability to tolerate a procedure change.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) has received the patient side manipulator (psm2) involved with this complaint and complaint the device evaluation.The psm2 was returned for failure analysis, and the reported failure (non-intuitive motion) was unable to be reproduced, nor could it be confirmed as having occurred.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.
Event or Problem Description
Refer to h10/h11 for follow-up information.

• Brand Name: DAVINCI SI
• Common Device Name: PATIENT SIDE CART, RECERTIFIED
• 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: 16237938
• Report Number: 2955842-2023-10294
• Device Sequence Number: 12413579
• Product Code: NAY
• UDI-Device Identifier: 00886874110775
• UDI-Public: (01)00886874110775
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K081137
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2023

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
• Operator of Device: Health Professional
• Device Model Number: 380686-04
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/06/2023
• Supplement Date Received by Manufacturer: 04/27/2023
• Initial Report FDA Received Date: 01/24/2023
• Supplement Report FDA Received Date: 05/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian