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	12/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive the 6mm monopolar cautery instrument to perform failure analysis.Failure analysis investigations confirmed the customer reported complaint.The instrument was analyzed and it 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 would have measured approximately 5.34mm x 2.57mm in size.The broken tip adapter also caused the contacts within the tip to break.The broken tip adapter made it difficult to install a tip and caused the tip to not be securely attached.Additional finding(s): the instrument was found to have detached fragments that were likely caused by the broken instrument tube adapter and broken contacts.The instrument had broken contacts due to a damaged tube adapter.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 prior to start of a da vinci-assisted surgical procedure, the 6mm monopolar cautery instrument was observed to have an incomplete tip.The procedure was aborted due to patient having too much perinephric fat making it difficult to identify the critical structures necessary for procedure completion and it was being referred to a higher level of care.Intuitive surgical inc., (isi) followed up with the robotic coordinator and obtained the following additional information: no fragments were reported to have fallen from the instrument while in use during the last procedure.The patient has not returned to the hospital due to experiencing any post-surgical complications related to retention of foreign material.

• 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: 23985324
• Report Number: 2955842-2026-00109
• Device Sequence Number: 4630181
• Product Code: NAY
• UDI-Device Identifier: 00886874114315
• UDI-Public: (01)00886874114315(10)U11230413
• Combination Product (Y/N): N
• Initial Reporter State: SD
• 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): 01/06/2026

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: U11230413 0002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/16/2025
• Initial Report FDA Received Date: 01/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/13/2023
• 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 Age: 48 YR
• Patient Sex: Male
• Patient Weight: 191 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White