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

Model Number	430004-62
Medical Device Problem Codes	Material Fragmentation (1261); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/27/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a da vinci-assisted malignant mastectomy surgical procedure, the monopolar curved scissor (mcs) tip detached from the mcs instrument and fell inside the patient.After retrieving the mcs tip, it was discovered that a piece of plastic about 1 mm in size was missing from the end of the instrument where the mcs tip connects.A post-operative x-ray was performed; however, the results are unknown.The procedure was completed.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the mcs instrument was inspected prior to use, with no visible damage or abnormalities noted.During the surgical procedure, a device fragment fell inside the patient while the instrument was being used for dissecting and retracting tissue after approximately 30 minutes of use.The surgeon did not observe any functionality issues, and there was no collision between instruments or with hard materials.The fragment was not retrieved.No additional surgical procedure was performed to attempt retrieval of the missing fragment.The surgery was completed robotically without patient injury, and there have been no reported post-surgical complications or returns to the hospital related to a retained foreign object.
Additional Manufacturer Narrative
The mcs 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 1.4 mm x 1.6 mm was not returned with the instrument.A visual inspection was performed and there was no damage to the snake wrist cables, housing and shaft.Additionally, the instrument was found to have a detached fragment from the tube adapter.The area of the detached fragment measures approximately 1.4 mm x 1.6 mm size.The instrument was also found to have white residue observed on four of the clamping pulleys, located inside the backend of the instrument.The instrument was found to have multiple corroded bearings.The housing was removed for inspection and orange discoloration was observed on five bearings near the clamping pulleys and grip input, which indicates corrosion.Blank mdr fields: the missing patient information in sections a and b was either unknown, unavailable, not provided, or not applicable.The expiration date for section d4 is not applicable.Field d6 is blank because the product is not implantable.Information for the blank fields in section e1 is not available.Fields g5 and g7 are not applicable.Field h10 is blank as there are no related report numbers.

• 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: 24955386
• Report Number: 2955842-2026-21727
• Device Sequence Number: 5278666
• Product Code: NAY
• UDI-Device Identifier: 00886874114285
• UDI-Public: (01)00886874114285(11)250501(10)K10250501
• 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: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 04/22/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: 430004-62
• Device Catalogue Number: 430004
• Device Lot Number: K10250501 0031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/30/2026
• Initial Report FDA Received Date: 04/22/2026
• 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: Female