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

Model Number	476049-17
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the instrument for failure analysis evaluation.The force feedback cadiere forceps instrument was analyzed and found to have an unknown broken component.The detached fragment, resulting from the breakage, was returned along with the instrument.Examination showed that adjacent components were intact and exhibited no signs of damage.A review of the provided image was performed.The following additional information was provided: the quality of the image made it difficult to determine precisely which part the fragment may belong to.
Event or Problem Description
It was reported that during a da vinci-assisted gastric bypass procedure, a small curved metallic fragment fell from the force feedback cadiere forceps instrument and was retrieved from the patient's abdomen during the same procedure.The customer confirmed that all visible fragments were retrieved; one piece was identified and removed using a laparoscopic grasper.The piece was small, and no post-operative imaging such as x-ray or ultrasound was performed.It was not known whether the patient had returned to the hospital, but no complications or additional surgical procedures were reported.

• Brand Name: FORCE FEEDBACK
• Common Device Name: FORCE FEEDBACK CADIERE 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: 24917957
• Report Number: 2955842-2026-22087
• Device Sequence Number: 10420430
• Product Code: NAY
• UDI-Device Identifier: 00886874125564
• UDI-Public: (01)00886874125564(10)K10250915
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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,Health Professional
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• 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: 476049-17
• Device Catalogue Number: 476049
• Device Lot Number: K10250915 0022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/23/2026
• Initial Report FDA Received Date: 04/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/15/2025
• 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