MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST SP; MONOPOLAR CAUTERY INSTRUMENT

Model Number	430007-62
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) has received the instrument; however, failure analysis is still ongoing.Additional information is being gathered to determine the contribution of the device to the customer reported issue.
Event or Problem Description
It was reported that during central processing, the beige distal plastic tip is broken and cracked on the working end of the 6mm monopolar cautery instrument.There was no report of patient involvement or patient injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the issue was discovered during cleaning process before cases.Patient demographics were not provided.
Event or Problem Description
Refer to h11 for follow-up information.
Additional Manufacturer Narrative
Intuitive surgical inc.(isi) received the sp monopolar cautery instrument for failure analysis investigation.The instrument was analyzed and found to have a cracked tube adapter.The crack of the tube adapter measures approximately 0.31mm x 3.19mm.There was no material missing as a result.Tube adapter cracks are typically caused during installation / removal of the mci tip accessory.The probable root cause of a damaged tube adapter is attributed to either tip accessory installation issues or damage during use.

• Brand Name: ENDOWRIST SP
• Common Device Name: MONOPOLAR CAUTERY INSTRUMENT
• 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: 23701732
• Report Number: 2955842-2025-47192
• Device Sequence Number: 10691070
• Product Code: NAY
• UDI-Device Identifier: 00886874114315
• UDI-Public: (01)00886874114315(11)240822(10)U10240822(91)0007
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2025

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: 430007-62
• Device Catalogue Number: 430007
• Device Lot Number: U10240822 0004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/14/2025
• Supplement Date Received by Manufacturer: 12/04/2025
• Initial Report FDA Received Date: 12/03/2025
• Supplement Report FDA Received Date: 12/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/22/2024
• 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