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

Model Number	430100-02
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2026
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 hysterectomy surgical procedure, the monopolar curved scissors (mcs) tip connection broke during catheterization, causing the tip to detach and fall into the abdominal cavity.All visible pieces of the tip were removed.The procedure was performed using a backup device, delaying the surgery by approximately 10 minutes.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: during the procedure, the connecting part between the tip and the instrument broke off resulting in fragments and the tip falling into the patient.These fragments were retrieved during the same procedure by the assistant using a laparoscopic instrument.The team visually confirmed that all fragments were removed.No post-operative imaging, such as x-rays or ultrasounds, was conducted to check for residual fragments.The patient has not returned with any post-surgical complications related to a retained foreign object.There were no injuries or complications as a result of this incident, nor was any additional surgical procedure required for fragment removal.While the instrument is available to be returned to intuitive surgical for evaluation, there are no photos or videos documenting the event.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The monopolar curved scissors (single port) instrument was analyzed and 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 1.6mm x 2.8mm, was not returned with the instrument.Visual inspection was performed and there was no damage to the snake wrist cables, housing and shaft.Additionally, the instrument was found to have residue.White residue was observed on two of the clamping pulleys, located inside the backend of the instrument.The complaint was confirmed by failure analysis.A review of the site's system logs for the reported procedure date revealed there were no related system errors to have occurred during the surgical procedure that would have likely caused or contributed to the reported complaint.
Event or Problem Description
Refer to h11 for follow-up information.

• 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 ; 4085232100
• MDR Report Key: 24698383
• Report Number: 2955842-2026-17730
• Device Sequence Number: 15980018
• Product Code: NAY
• UDI-Device Identifier: 00886874123454
• UDI-Public: (01)00886874123454(11)251209(10)K11251209
• 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): 05/04/2026

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: 430100-02
• Device Catalogue Number: 430100
• Device Lot Number: K11251209 0018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/03/2026
• Supplement Date Received by Manufacturer: 04/20/2026
• Initial Report FDA Received Date: 03/26/2026
• Supplement Report FDA Received Date: 05/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/09/2025
• 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