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

Model Number	470205-19
Medical Device Problem Codes	No Device Output (1435); Device Dislodged or Dislocated (2923); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The fenestrated bipolar forceps instrument was analyzed, and failure analysis found the primary failure of expected condition to be related to the customer reported complaint.The part was returned with a reported complaint that does not affect functionality.When the instrument was tested on the in-house system, it was found to have zero lives remaining, and the end-of-life indicator had rotated to red.Review of the instrument logs did not yield any results.Once all instrument lives are exhausted, the system will no longer recognize the instrument, preventing further use.Failure analysis identified damaged conductor wire insulation at the yaw pulley.Although the internal conductor wires were exposed, there was no insulation fragmentation, and the wires were neither frayed nor fully broken.The instrument passed the electrical continuity test.Further inspection revealed no abnormally sharp or damaged components that could have contributed to the cable damage.The instrument was also found to have a dislodged pitch cable at the proximal end within the housing.A visual inspection of the backend revealed no cracked clamping pulley, input disk, or input shaft that could have caused the cable dislodgement.The probable root cause of damaged conductor wire insulation is attributed to damage from mechanical impact.Accidental drops of the instrument or inadvertent collisions with other instruments or hard surfaces during handling or usage can damage the insulation.The probable root cause is attributed to a loss of cable tension.A cracked clamping pulley and/or input shaft can cause the cable to become dislodged at the proximal end.When the clamping pulley and/or input shaft is cracked, the cable can dislodge as the input could "slip" with respect to its internal shaft causing the loss of cable tension.A cracked clamping pulley and/or input shaft can be caused by improper cleaning or sterilization techniques used during reprocessing.A dislodged cable at the proximal end can then result in the cable becoming derailed or loose at the distal end.
Event or Problem Description
It was reported that prior to the start of a da vinci-assisted surgical procedure, the fenestrated bipolar forceps instrument could not be used after being installed on the system.The procedure was aborted.No patient involvement with no reported injury.

• Brand Name: ENDOWRIST
• 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: 25262573
• Report Number: 2955842-2026-26144
• Device Sequence Number: 14807534
• Product Code: NAY
• UDI-Device Identifier: 00886874112359
• UDI-Public: (01)00886874112359(11)250522(10)K10250522(91)0002
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K131861
• 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): 05/22/2026

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: 470205-19
• Device Catalogue Number: 470205
• Device Lot Number: K10250522 0437
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/01/2026
• Initial Report FDA Received Date: 05/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/22/2025
• 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