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

Model Number	431100-02
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the 6 mm monopolar curved scissors (mcs) instrument was observed to have a defective tip.The procedure was completed with no reported injury.
Additional Manufacturer Narrative
The 6 mm monopolar curved scissors (mcs) instrument involved in this complaint has not been received and/or tested by failure analysis as of the date of this report.If the product is received and evaluated, a supplemental mdr will be submitted.
Event or Problem Description
Refer to h11 for follow-up information.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the da vinci product to perform failure analysis.The single port (sp) monopolar curved scissors (mcs) instrument was analyzed and found to have a broken drive rod.Due to the broken drive rod, the tube adapter was unable to move up and down.A mcs tip was unable to be installed.The instrument housing was opened up and the drive rod was completely removed.The distal end of the drive rod appears broken.When lined up with the instrument main tube, the damage appeared near the distal joggle joint.Visual inspection was performed and found no external damage to the housing.Input disks for roll, joggle, pitch and yaw actuated without any issues.The complaint regarding a tip defect was confirmed by failure analysis.The probable root cause of a broken distal drive rod is attributed to component susceptibility to damage.Damage can result from mechanical impact, such as accidental drops of the instrument or inadvertent collisions with hard surfaces during handling or usage.

• 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: 23653852
• Report Number: 2955842-2025-46433
• Device Sequence Number: 4903669
• 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): 01/26/2026

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: 431100-02
• Device Catalogue Number: 431100
• Device Lot Number: K10250501 0026
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/11/2025
• Supplement Date Received by Manufacturer: 01/06/2026
• Initial Report FDA Received Date: 11/26/2025
• Supplement Report FDA Received Date: 01/26/2026
• 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
• Patient Sex: Unknown