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

Model Number	380675-04
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the clinical sales representative (csr) contacted the technical support engineer (tse) and reported the patient side manipulator (psm)3 was having insertion movement issue.The tse reviewed logs and confirmed informational error 22023 on psm3 axis.The csr confirmed power cycle and drape reset was already done but it didn't work.The field service engineer (fse) will visit for further troubleshooting.The procedure was completed as planned with no reported injury.Intuitive surgical, inc.(isi) followed up with the clinical sales representative (csr) and obtained the following additional information: the procedure was completed with three arms.
Additional Manufacturer Narrative
An investigation was completed to determine the cause of this reported event.An intuitive surgical, inc.(isi) field service engineer (fse) was dispatched to the customer site to further investigate the reported event.The fse replaced the patient side manipulator (psm3) and the system tested and verified ready for use.Intuitive surgical, inc.(isi) has received the psm for evaluation.However, the product analysis has not yet been completed.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product involved with this complaint to perform a failure analysis.The patient side manipulator (psm) was analyzed and found to have no failures, but errors were confirmed in the logs.A visual inspection was performed; the arm was installed onto the system and powered up.A sine cycle and test drive were performed without issue.All tests performed and passed.The complaint was not confirmed based on the failure analysis.
Event or Problem Description
Refer to h10/h11 for follow-up information.

• 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 95051
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer Contact: izabel nielson ; 3410 central expressway; santa clara, CA 95051 ; 4085232100
• MDR Report Key: 19569533
• Report Number: 2955842-2024-15800
• Device Sequence Number: 6197509
• Product Code: NAY
• UDI-Device Identifier: 00886874110737
• UDI-Public: (01)00886874110737
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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,Followup
• Report Date (Section B): 05/23/2024

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: 380675-04
• Device Catalogue Number: 380675
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/23/2024
• Supplement Date Received by Manufacturer: 07/25/2024
• Initial Report FDA Received Date: 06/19/2024
• Supplement Report FDA Received Date: 08/20/2024
• 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: Prefer Not To Disclose