MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DA VINCI SP; PATIENT SIDE CART

Model Number	380601-48
Medical Device Problem Code	No Device Output (1435)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An intuitive surgical, inc.(isi) field service engineer (fse) was dispatched to the customer site to further investigate the reported event.The fse went on site and replaced the patient side manipulator (psm) 1 proactively.The system was tested and verified as ready for use.Isi has received the psm involved with this complaint to perform failure analysis; however, the evaluation has not been completed.The drape accessory has not been received for failure analysis evaluation.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, patient side manipulator (psm) 1 was not continuously draped.The disc and drape of the first arm are connected so that the disc should rotate, but the disc did not rotate.An intuitive surgical, inc.(isi) technical support engineer (tse) had the customer exercise the presence pins on the psm and try the sterile adapter, but the issue persisted.The procedure was aborted prior to port placement; there was no patient involvement.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: it was confirmed that psm1 was the problem, so psm 1 was replaced and the procedure was aborted.
Additional Manufacturer Narrative
Updated fields: g3, g6, h2, h3, h6, and h11.Device evaluation: the patient side manipulator (psm) was returned for failure analysis evaluation.The logs showed multiple sterile adaptor engagement errors were seen, confirming the fault occurred in the field.The error was pointing to the psm failing to engage the preload immediately after latch check.During visual inspection, no issues were seen that would be related to the reported problem.The unit was installed onto a golden system where the psm had functioned as designed.Multiple sterile adapters and instruments were installed however no faults or errors were triggered.The unit was then installed onto a psc fixture test platform where it passed all testing within specification.
Event or Problem Description
Refer to h11 for follow-up information.

• Brand Name: DA VINCI SP
• Common Device Name: PATIENT SIDE CART
• 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: 24938308
• Report Number: 2955842-2026-21536
• Device Sequence Number: 17438152
• Product Code: NAY
• UDI-Device Identifier: 00886874114605
• UDI-Public: (01)00886874114605
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K182371
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2026

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: 380601-48
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/24/2026
• Supplement Date Received by Manufacturer: 05/06/2026
• Initial Report FDA Received Date: 04/21/2026
• Supplement Report FDA Received Date: 05/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/20/2023
• 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: Initial
• 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