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

Model Number	430007-62
Medical Device Problem Code	No Device Output (1435)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The 6mm monopolar cautery instrument was analyzed and found to have a recognition failure based on log review but was not replicated during in-house testing.A review of logs showed 1 number of 31009 error codes, indicating instrument sensors missing.A tool was partially detected on patient side manipulator (psm)1, one or more of the tool sensors were not detected.The instrument was placed and driven on an in-house system.The instrument passed the recognition and engagement tests.The instrument moved intuitively with a full range of motion in all directions.The instrument was retested and passed recognition and engagement on both attempts.The housing was removed for inspection, and the instrument did not exhibit any internal physical damage.Fa found additional observations that are related to the customer reported complaint: the instrument was found to have a broken instrument 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 was not returned and measured approximately 2.26 x 3.35 mm in size.The instrument was found to have a broken electrical contact.Both sides of the electrical contact were found broken in the over molded seal adapter location.Both pieces, measuring roughly.90 mm x 3.72 mm (x2) in size were not returned with the instrument.The complaint was confirmed by failure analysis.The probable root cause of recognition failure is attributed to communication issues with the rfid chip.
Event or Problem Description
It was reported that during a da vinci-assisted cholecystectomy surgical procedure, the 6mm monopolar cautery instrument would not recognize.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the customer confirmed that no fragments fell into the patient and there were no reports of fragments detaching from the device while used within the patient.No actions related to fragment retrieval were required.No post-surgical complications or hospital returns associated with retained foreign material were reported.

• 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: 25238072
• Report Number: 2955842-2026-25886
• Device Sequence Number: 18797442
• Product Code: NAY
• UDI-Device Identifier: 00886874114315
• UDI-Public: (01)00886874114315(11)250508(10)K10250508
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 05/20/2026

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: 430007-62
• Device Catalogue Number: 430007
• Device Lot Number: K10250508 0011
• 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: 05/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/08/2025
• 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