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

Model Number	431100-02
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/02/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The monopolar curved scissors (mcs) tip/instrument has not been received for failure analysis evaluation.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, single port (sp) monopolar curved scissors (mcs) tip fell into a patient after the scissor tip connection was broken.The procedure was completed.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the instrument was inspected before use and found to be in normal condition, with no damage identified.During the procedure, a device fragment fell inside the patient while suturing in the abdominal cavity; the surgeon believed this was due to a collision between instrument arms.Only some fragments were retrieved, as the remainder were too small, but no additional surgical intervention was needed.The procedure was completed robotically, and the surgeon confirmed the residual fragments were small enough to pass through the drain.There was no post-operative tests or imaging studies performed.The instrument and fragments are not available for return, and the scissor tip had been discarded.There were no images or videos of the devices or procedure for review.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The monopolar curved scissors (mcs) (single port) instrument was analyzed and found to have a broken instrument tube adapter.The broken piece was not returned and measured approximately 1.88mm x 2.66 mm in size.An in-house mcs tip accessory was successfully installed despite the damage.Manual tip articulation was performed and passed.The instrument was placed on the in-house system testing and passed energy delivery.The instrument moved intuitively with full range of motion in all directions, with the grip opening and closing properly when the grip knob was manually rotated.The housing was removed and there was no damage found.
Event or Problem Description
Refer to h11 for follow-up information.

• 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: 24442310
• Report Number: 2955842-2026-06624
• Device Sequence Number: 16064400
• Product Code: NAY
• UDI-Device Identifier: 00886874124048
• UDI-Public: (01)00886874124048(11)250501(10)K10250501
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2026

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: K10250501 0024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/01/2026
• Supplement Date Received by Manufacturer: 02/26/2026
• Initial Report FDA Received Date: 02/25/2026
• Supplement Report FDA Received Date: 03/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2025
• 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