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

Model Number	430004-62
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation was completed to determine the cause of this reported event.Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The monopolar curved scissors (mcs) instrument was analyzed and found to have a broken drive rod.The complaint was confirmed by failure analysis, which indicates that the device may have contributed to the customer reported issue.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.Additionally, improper cleaning during reprocessing, such as prolonged exposure of the accessory to harsh cleaning agents, can lead to instrument damage.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, single port (sp) monopolar curved scissors (mcs) instrument had opening/closing malfunction.A back-up instrument was used to resolve the reported issue.The procedure was completing as planned with no reported injury.

• 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: 25037185
• Report Number: 2955842-2026-23320
• Device Sequence Number: 13242105
• Product Code: NAY
• UDI-Device Identifier: 00886874114285
• UDI-Public: (01)00886874114285(11)250522(10)K10250522
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K182371
• 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
• Report Date (Section B): 04/29/2026

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: 430004-62
• Device Catalogue Number: 430004
• Device Lot Number: K10250522 0006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/10/2026
• Initial Report FDA Received Date: 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/22/2025
• 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