MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC EndoWrist SP; MONOPOLAR CURVED SCISSORS

Model Number	430100-02
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the joint was not bending properly and kept moving differently from the console input.Customer tried detaching it to reassemble the sheath, and replaced it with a new one, but the same issue persisted.After switching to a different monopolar curved scissors arm, it functioned correctly.The procedure was completed with no reported injury.
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.Or staff, contacted tech support mid-procedure to report they had a recoverable error earlier in the procedure resulting in the system restarting on it's own.Prior to calling they restarted the system and were continuing as planned.As the caller was explaining what happened communication errors returned pointing to the blue fiber cable connection to console 1 plugged into the 3rd from the top port on the back of the core.Tse walked the caller through powering the system down and reseated the fiber cables.Caller was not able to perform a hard power cycle and powered the system back on resulting in a error 307 on console 1.Customer elected to undock and finish the case as planned.Field engineer (fe) replaced personality module surgeon console (pmsc) as per isi procedures.System is operational and verified as ready for use.Isi did receive a da vinci product involved with this complaint to perform failure analysis, but evaluation has not been completed as of the date of this report.The complaint was confirmed based on the field evaluation, which indicates that the device may have contributed to the customer reported issue.

• Brand Name: EndoWrist SP
• Common Device Name: MONOPOLAR CURVED SCISSORS
• 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 ; +1(408)523-2100
• MDR Report Key: 50895164
• Report Number: 2955842-2026-39864
• Device Sequence Number: 20290956
• Product Code: NAY
• UDI-Device Identifier: 00886874123454
• UDI-Public: (01)00886874123454(11)260416(10)K10260416
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K241814
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 09/25/2026

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: 430100-02
• Device Catalogue Number: 430100
• Device Lot Number: K10260416 0006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/28/2026
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/16/2026
• 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