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

Model Number	431100-02
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The mcs tip instrument has been received for failure analysis evaluation.The instrument was found to have a broken tube adapter.This component is located at the distal end of the instrument and serves as the interface between the instrument and the user installed tip accessory.The broken piece, measuring approximately 1.6 mm x 2.3 mm and was not returned with the instrument.Visual inspection was performed and there was no damage to the snake wrist cables, housing and shaft.Additional observation(s) related to the customer reported complaint: the instrument was found to have a detached fragment.Visual inspection was performed and the detached fragment was broken from the tube adapter.The area of the detached fragment measures approximately 1.6 mm x 2.3 mm size.Additional observation(s) not reported by site: the instrument was found to have residue.Visual inspection was preformed and white residue was observed on all four of the clamping pulleys, located inside the backend of the instrument.The instrument was found to have a corroded bearing.The housing was removed for inspection and orange discoloration was observed on a bearing near the clamping pulley, which indicates corrosion.
Event or Problem Description
Refer to h11 for follow-up information.
Additional Manufacturer Narrative
The mcs instrument has not been received for failure analysis evaluation.Note: refer to medwatch report (mdr) with mfr.Report #2955842-2026-19710 for mdr submission of the event against the mcs tip accessory.
Event or Problem Description
It was reported that during a da vinci-assisted left hemicolectomy procedure, a fragment from the sp monopolar curved scissors (mcs) instrument broke off.The mcs tip along with a small plastic piece from the instrument was found and removed from the patient.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: prior to surgery, the mcs instrument and tip were carefully inspected, and no issues or damage were observed.During the procedure, which involved dissecting, a fragment of the instrument unexpectedly fell inside the patient after approximately three hours of use.The surgeon was unable to determine the cause of the incident, noting that there were no prior functional issues and no collisions with other instruments or hard material.The fragment was retrieved at the bedside with all fragments accounted for and no need for additional procedures or post-operative imaging.The surgical procedure was completed using a backup mcs instrument and no patient injuries were observed.The patient has not returned to the hospital with any post-operative complications.

• Brand Name: ENDOWRIST SP
• Common Device Name: MONOPOLAR CURVED SCISSORS ER
• 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: 24723125
• Report Number: 2955842-2026-19709
• Device Sequence Number: 10204475
• Product Code: NAY
• UDI-Device Identifier: 00886874124048
• UDI-Public: (01)00886874124048(10)K10251211
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K241814
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: 431100-02
• Device Catalogue Number: 431100
• Device Lot Number: K10251211 0026
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/04/2026
• Supplement Date Received by Manufacturer: 04/02/2026
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 04/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/11/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown