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

Model Number	476205-17
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during central processing, the instrument end piece was cracked.There was no report of patient involvement or 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.Failure analysis investigations replicated and confirmed the customer-reported complaint.The instrument was found to have a broken main tube approximately 45mm from the distal tip.A fragment from the distal overmold, measuring approximately 8mm x 12.5mm, was not returned with the instrument.Components adjacent to the broken main tube showed damage, which may indicate potential mishandling or misuse.Scratches were observed roughly 95mm proximal to the distal tip.Common causes of the failure mode "broken instrument main tube" include damage during use, such as accidental dropping or inadvertent collisions with other instruments.Excessive lateral loading can also cause the main tube wall to collapse inward, resulting in cracking and subsequent breakage.The root cause is attributed to user handling.Additional observations related to the customer complaint: the instrument had a detached fragment related to the broken distal overmold of the main tube.Detached fragments can be directly caused by broken components, such as the main tube.The fragment, measuring 8mm x 12.5mm (width x length), was not returned with the unit.The location of this missing fragment is roughly 45mm proximal to the distal tip.The root cause is attributed to the user.Additional observations unrelated to the customer complaint: the instrument exhibited various scratches on the main tube.These scratches and abrasions are considered cosmetic damage.The scratches measured approximately 3mm to 5.66mm in length and are not axially aligned with the tube axis.Material is missing from the surface of the main tube.Components adjacent to the scratched main tube also showed damage, which may indicate potential mishandling or misuse.Damage observed included a broken main tube approximately 45mm from the distal tip.Common causes of the failure mode "scratch marks / abrasions instrument main tube" are associated with damage during use, such as instrument collisions, abrasive cleaning, cleaning inside the body, or normal wear over time caused by friction against a cannula.The root cause is attributed to user handling.The probable root cause is attributed to damage during use, which may result from an accidental drop of the instrument or inadvertent collisions with other instruments.Excessive side loading on the instrument can also cause the main tube wall to collapse inwards leading to cracking and subsequent breakage.This issue can be resolved by using an alternate instrument to complete the procedure.

• Brand Name: FORCE FEEDBACK
• Common Device Name: FORCE FEEDBACK 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: 24990562
• Report Number: 2955842-2026-22760
• Device Sequence Number: 10043790
• Product Code: NAY
• UDI-Device Identifier: 00886874125588
• UDI-Public: (01)00886874125588(10)K10251013
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K243641
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 04/24/2026

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: 476205-17
• Device Catalogue Number: 476205
• Device Lot Number: K10251013 0016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/07/2026
• Initial Report FDA Received Date: 04/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/13/2025
• 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