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

Model Number	431100-01
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/17/2025
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.The instruments tube adapter and distal end were inspected and found to have no broken components.An in-house mcs tip was installed on the instrument.The instrument was then tested on an in-house system.The instrument passed the recognition and engagement tests.The instrument moved intuitively with full range of motion in all directions.The grip tips opened and closed properly.Additional findings not reported by site: the instrument was found to have scratch marks / abrasions on the tube adapter.There was no material missing as a result.The probable root cause is attributed to issues during installation of the mcs tip accessory.
Event or Problem Description
It was reported that during central processing, single-port (sp) monopolar curved scissors (mcs) distal tip was found broken.There was no report of patient involvement.

• 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: 22463706
• Report Number: 2955842-2025-29138
• Device Sequence Number: 20852698
• Product Code: NAY
• UDI-Device Identifier: 00886874124048
• UDI-Public: (01)00886874124048(11)240826(10)U11240826(91)0001
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K241814
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 06/17/2025

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: 431100-01
• Device Catalogue Number: 431100
• Device Lot Number: U11240826 0006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/17/2025
• Initial Report FDA Received Date: 07/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/26/2024
• 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: Reuse
• 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