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

Model Number	476205-17
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/10/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did not receive a da vinci product to perform failure analysis.
Event or Problem Description
It was reported that after a da vinci-assisted distal gastrectomy procedure, a wire on the force feedback fenestrated bipolar forceps (fbf) instrument was found to be broken.It is currently unknown whether any fragments may have fallen inside the patient or if fragments were retrieved.The surgeon did not observe any functional issues with the instrument during the procedure, and there were no collisions with any other instrument or tool during the procedure.The procedure was successfully completed robotically without complications, and no additional procedure or post-operative imaging studies, such as x-rays or ultrasound, were performed to assess for retained fragments.
Event or Problem Description
Refer to h11 for follow-up information.
Additional Manufacturer Narrative
Updated sections: d9, h2, h3, h6, h11.Device evaluation: intuitive surgical, inc.(isi) received the force feedback fenestrated bipolar forceps instrument for failure analysis evaluation.The instrument was found to have a frayed grip cable at the distal idler pulley, with several broken wires; however, the cable itself was not fully broken.There was no discoloration, corrosion, or contamination observed on the cable, that would occur from improper flushing or rinsing during reprocessing.Further inspection revealed mechanical indentations and burrs on the edge of the distal idler pulley, but no pieces were missing.The grip cables adjacent to the indented pulley also showed damage.The grip cable was frayed as a result from the indented distal pulley.
Additional Manufacturer Narrative
Updated sections: g3, g6, h2, h6, h11.Additional device evaluation: further investigation confirmed initial failure analysis findings.The instrument grip cables were observed to be frayed near the proximal clevis pulleys, although the cables were not fully broken.Further inspection revealed that the chamfer at the proximal clevis ear was not appropriately sized, resulting in the proximal clevis to appear not to be as angled, when compared to the nominal beveled clevis edge.Additionally, the distal idler pulley showed signs of damage, which likely resulted from the interaction between the proximal clevis ear and the distal idler pulley, attributable to the lower chamfer.It was confirmed that the proximal clevis used in this instrument was manufactured prior to the drawing update, so it would not have been manufactured using the improved supplier controls for the clevis ear chamfer.
Event or Problem Description
Refer to h11 for follow-up information.

• 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: 23498795
• Report Number: 2955842-2025-42584
• Device Sequence Number: 9115948
• Product Code: NAY
• UDI-Device Identifier: 00886874125588
• UDI-Public: (01)00886874125588(11)250206(10)U10250206
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K243641
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/17/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: 476205-17
• Device Catalogue Number: 476205
• Device Lot Number: U10250206 0053
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/12/2025
• Supplement Date Received by Manufacturer: 12/03/2025; 03/27/2026
• Initial Report FDA Received Date: 11/07/2025
• Supplement Report FDA Received Date: 12/30/2025; 04/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/06/2025
• 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: ISIFA2024-09-C
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DA VINCI INSTRUMENTS AND ACCESSORIES
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown