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

Model Number	430004-62
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The monopolar curved scissors (mcs) instrument has been returned and evaluated by the failure analysis (fa) team.The instrument was found to have a broken tube adapter.For clarification, the tip accessory cannot be installed on the instrument due to 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 1.7mm x 4.2mm was not returned with the instrument.Visual inspection was performed and there was no damage to the snake wrist cables, housing and shaft.Fa found additional observations that are related to the customer reported complaint: the instrument was found to have a detached fragment.Visual inspection was performed and the detached fragment was broken from the tube adapter.The area of the detached fragment measures approximately 1.7mm x 4.2mm size and located at the distal tip.The instrument was found to have scratch marks and abrasions on the tube adapter.During visual inspection, several scratch marks and abrasions was observed on the tube adapter, located at the distal tip of the instrument.The complaint was confirmed by failure analysis.The probable root cause of a damaged tube adapter is attributed to either tip accessory installation issues or damage during use.
Event or Problem Description
It was reported that the customer experienced an issue with the 6mm monopolar curved scissors instrument.The customer reported event has no report of patient injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the customer confirmed that the missing material/damage was identified during reprocessing and did not occur while the device was in use within a patient.There were no reports of fragments falling from the device during patient use.No post-surgical complications or hospital returns related to retained foreign material were reported.

• 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: 25308461
• Report Number: 2955842-2026-26607
• Device Sequence Number: 9861419
• Product Code: NAY
• UDI-Device Identifier: 00886874114285
• UDI-Public: (01)00886874114285(11)241024(10)K11241024(91)0003
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K182371
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 05/27/2026

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: K11241024 0034
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/01/2026
• Initial Report FDA Received Date: 05/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2024
• 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