MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST SP; FENESTRATED BIPOLAR FORCEPS

Model Number	430011-57
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the single port fenestrated bipolar forceps instrument tip did not meet.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 damage was identified outside of a surgical procedure, not while in use within a patient.Therefore, there is no report of a fragment falling into the patient's anatomy.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive the single port fenestrated bipolar forceps instrument to perform failure analysis (fa).Fa was able to confirm/reproduce the reported complaint.The instrument was found to have one (1) severely bent grip on upper grip, causing misalignment of the grip-tips.There was a 2.29mm offset at the tips.The grips were found to have damage at molded insulator.The inputs were articulated manually and passed.The probable root cause is attributed to damage during either use or reprocessing, as severe misalignment of grip tips can be due to accidental drops, incorrect instrument tray or sink sizes for reprocessing, or overloading the tips by applying excessive force on the jaws.Additional observation related to the customer complaint: the instrument was found to have a broken molded insulator on the upper jaw.The broken piece measures approximately 1.50 mm x 1.94mm, confirming that a fragment detached from the instrument and was not returned with the instrument.The grip base for the grip with the molded insulator does appear to be bent.The instrument passed continuity test.Common causes of the failure mode broken molded insulator can result from mechanical impact or excessive force applied to the jaws, such as an accidental drop of the instrument.Additional observation(s) not reported by site: the instrument was found to have clamping pulley residue.The instrument's housing was removed and upon inspection, the instrument was found to have an excessive amount of dried, white residue on the clamping pulleys for inputs joggle left/right, yaw, pitch, and joggle up/down, located inside the backend of the instrument.Common causes of the failure mode residue instrument clamping pulleys are attributed to improper cleaning or sterilization techniques used during reprocessing, which may involve prolonged exposure of the instrument to harsh cleaning agents or insufficient flushing.The instrument was found to have corroded bearings.The instrument was visually inspected through camera head inspection using a housing removal tool to remove the housing cover.Upon inspection, the instrument exhibited orange color discoloration on four bearings.

• Brand Name: ENDOWRIST SP
• Common Device Name: FENESTRATED BIPOLAR FORCEPS
• 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: 24624735
• Report Number: 2955842-2026-16594
• Device Sequence Number: 12933755
• Product Code: NAY
• UDI-Device Identifier: 00886874114339
• UDI-Public: (01)00886874114339(10)K10240404
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 03/17/2026

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: 430011-57
• Device Catalogue Number: 430011
• Device Lot Number: K10240404 0011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/20/2026
• Initial Report FDA Received Date: 03/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/04/2024
• 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