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

Model Number	380675-02
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An isi field service engineer (fse) was dispatched to the customer site to further investigate the reported complaint.The fse replaced the patient side manipulator (psm) to resolve the issue.The system was tested and verified as ready for use.The psm is expected to be returned for analysis, but it has not yet been received.Therefore, the root cause of the customer reported failure mode could not be determined.A follow-up mdr will be submitted when the item has been received and failure analysis has completed their investigation.Intuitive surgical inc.(isi) technical support engineer (tse) verified event date and system serial # (b)(4) during the service support call.No photo or video was provided by the site for review.This complaint is considered a reportable event due to the following conclusion: the customer experienced some resistance from the arm 2 after the start of the procedure.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 conversion/abortion.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, an intuitive surgical (is) field service engineer (fse) was contacted for assistance.Some resistance in arm 2 was observed.Logs were clean but according to the customer the arm made unusual noise and wanted troubleshooting for arm 2.The procedure was completed with no patient injury.Intuitive surgical (is) contacted the site/reporter and obtained the following additional information regarding this event: the system functionality was checked upon powering on the system, the system initially powered on without errors.There is no traceable information about how long had the surgery been in progress when the problem occurred.The surgeon was able to solve the problem after rebooting the system.The procedure was completed with 4 arms and no specific information about the procedure delay has been provided.

• Brand Name: DAVINCI SI
• Common Device Name: PATIENT SIDE CART, 4-ARM, 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: 15474782
• Report Number: 2955842-2022-14129
• Device Sequence Number: 11486016
• Product Code: NAY
• UDI-Device Identifier: 00886874110737
• UDI-Public: (01)00886874110737
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K123463
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 08/23/2022

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
• Operator of Device: Health Professional
• Device Model Number: 380675-02
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/23/2022
• Initial Report FDA Received Date: 09/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Age: 71 YR
• Patient Sex: Male
• Patient Weight: 98 KG