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

Model Number	430007-57
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive the single port monopolar cautery instrument to perform failure analysis (fa).Fa was not able to confirm nor reproduce the reported complaint.Energy delivery was tested six times at different angles and delivered energy consistently.The instrument was tested on an in-house system and passed the recognition and engagement tests.The instrument moved intuitively with full range of motion in all directions.There was no problem detected.The probable root cause of the customer reported issue cannot be determined based on the failure analysis results.Additional findings unrelated to the reported complaint: the adapter overmold was found to have damage.A visual inspection of the adapter overmold for damage such as cracks, indentations, or missing material was performed and failed due to a crack on the side of the adapter.The crack measured at 3.48mm in length from the distal tip.The probable root cause is attributed to either tip accessory installation issues or damage during use.The electrical contact was found to be broken and to have detached fragments.A visual inspection of the electrical contact for damage such as cracks, indentations, or missing material was performed and failed due to damage on two of the four electrical contact tabs.The damaged appeared to have detached fragments.The two longer electrical contact tabs were the tabs confirmed to have the detached fragments.The damage is estimated at.8mm by 1.2mm.The probable root cause of the detached fragment is attributed to damage during use.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, a single port monopolar cautery instrument exhibited no energy.The procedure was completed with no reported patient injury.

• 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: 24426270
• Report Number: 2955842-2026-07176
• Device Sequence Number: 8270100
• Product Code: NAY
• UDI-Device Identifier: 00886874114315
• UDI-Public: (01)00886874114315(10)U10230112
• 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: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 02/24/2026

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: 430007-57
• Device Catalogue Number: 430007
• Device Lot Number: U10230112 0028
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/30/2026
• Initial Report FDA Received Date: 02/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/12/2023
• 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