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

Model Number	476205-17
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the fenestrated bipolar forceps instrument to perform failure analysis.The instrument was found to have a broken main tube at the distal tip.Pieces measuring proximately 8.59mm x 6.57mm and 20.27mm x 8.62mm were not returned with the instrument.Components adjacent to this broken main tube did not show damage.
Event or Problem Description
It was reported that during a da vinci-assisted low anterior resection (lar) procedure, a piece of the distal shaft covering was noticed broken off from a fenestrated bipolar forceps (fbf) instrument.The staff noticed the issue while exchanging instruments.A fragment fell inside the patient and was removed from the patient during the same surgical procedure which was completed robotically.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the fbf instrument was not found to have any defects prior to the case.However, the instrument breakage was discovered after removal of the device from the patient.The instrument appeared to function properly during the case.A large fragment fell inside the patient but was retrieved using a laparoscopic instrument.All pieces were confirmed intact by reconstructing them on the back table.No additional surgery, imaging, or conversion from robotic technique was needed, and no injury or post-surgical complications occurred.

• 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: 25087354
• Report Number: 2955842-2026-23395
• Device Sequence Number: 13394967
• Product Code: NAY
• UDI-Device Identifier: 00886874125588
• UDI-Public: (01)00886874125588(10)U11250613
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 05/05/2026

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: U11250613 0112
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/14/2026
• Initial Report FDA Received Date: 05/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/13/2025
• 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.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown