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

Model Number	430011-57
Medical Device Problem Codes	Break (1069); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted prostatectomy - simple transvesical surgical procedure, the fenestrated bipolar forceps instrument's distal tip got broken outside the patient's anatomy.The procedure was completed with no reported injury.
Additional Manufacturer Narrative
An investigation was completed to determine the cause of this reported event.Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The fenestrated bipolar forceps instrument was analyzed and found to have a broken molded insulator.A visual inspection was performed, and the instrument was observed to have a broken lower molded insulator on the grip tips, with fragments of the lower molded insulator observed to be detached.The broken piece measured approximately 2.3mm x 9.3mm and was not returned with the instrument.There was no external damage to the housing and snake wrist cables.Each input disk was manually articulated and responded accordingly.The release buttons were functional.The instrument was found to have a detached fragment on the lower molded insulator from the grip tips.For clarification, part of the broken lower molded insulator was still attached to the instrument due to the conductor wire, but fragments of the lower molded insulator were observed detached.The instrument was found to have a lodged component.A visual inspection was performed, and the tube adapter was observed to have a lodged sheath coextrusion at the distal wrist.As a result of the lodged sheath coextrusion, the in-house instrument sheath was found to exhibit excessive friction during installation.The instrument was found to have an improper fit with an in-house instrument sheath.An in-house sheath was placed on the returned instrument, and friction was felt during installation, but when installing the in-house sheath to an in-house instrument, no friction was felt due to the lodged sheath coextrusion.The instrument was found to have a bent main tube located between shoulder one and shoulder two.The bent is approximately 418mm from the distal tip.The instrument was found to have residue observed on four of the clamping pulleys, located inside the backend of the instrument.The instrument was found to have multiple corroded bearings.The housing was removed for inspection, and orange discoloration was observed on six bearings near the clamping pulleys, grip input and section gear, which indicates corrosion.The complaint was confirmed by failure analysis.The probable root cause is attributed to damage during use, which may result from applying excess force on the instrument tip during handling, insertion, usage (overloading), or removal.The probable root cause of a bent main tube is attributed to damage during use, which may result from an accidental drop of the instrument or inadvertent collisions with other instruments.Applying excessive force on the instrument shafts and/or tips during handling, insertion, usage (overloading), or removal can also cause bending.The probable root cause is attributed to improper cleaning or sterilization techniques used in reprocessing, which may include prolonged exposure of the instrument to harsh cleaning agents or insufficient flushing.This issue can be resolved by using an alternate instrument to complete the procedure.

• 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: 25307406
• Report Number: 2955842-2026-26614
• Device Sequence Number: 13257132
• Product Code: NAY
• UDI-Device Identifier: 00886874114339
• UDI-Public: (01)00886874114339(10)U10230714
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 05/27/2026

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: U10230714 0001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/05/2026
• Initial Report FDA Received Date: 05/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/14/2023
• 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