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

Model Number	476205-17
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a da vinci-assisted donor nephrectomy procedure, a piece of the force feedback fenestrated bipolar forceps instrument shaft broke off.The fragment was retrieved during the same procedure which was completed robotically.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the instrument in question had been in use for over 30 minutes before the issue was noticed.Throughout the procedure, the surgeon did not observe any functional problems with the instrument.The instrument was not removed prior to the breakage and no resistance was felt by the surgical staff during removal of the instrument through the cannula.Both the cannula and the instrument revealed no visible damage other than the breakage from the instrument's shaft.When the instrument fragment fell inside the patient, it was retrieved in a single, intact piece using a laparoscopic grasper.All fragments were confirmed to be retrieved visually, as only one large piece was found, and no imaging (such as x-ray or ultrasound) was deemed necessary or performed to verify any retained fragments.The procedure was completed robotically without the need for conversion to open or traditional laparoscopic approaches, and no additional surgical procedures were required to manage the incident.The patient did not return to the hospital with any post-surgical complications.
Additional Manufacturer Narrative
The force feedback fenestrated bipolar forceps instrument has not been received for failure analysis evaluation.A review of an image provided by the customer was performed.The image showed a force feedback instrument with a broken distal overmold section of the main tube.
Event or Problem Description
Refer to h11 for follow-up information.
Additional Manufacturer Narrative
The following additional information was obtained: patients demographic information was provided.The customer stated that the fragment was lost during cleaning processing and will not be returned.Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The force feedback fenestrated bipolar instrument was analyzed and found to have a broken main tube approximately 0.328" from the distal tip.A piece measuring proximately 0.397¿ x 0.286¿ was not returned with the instrument.Components adjacent to this broken main tube showed damage.The instrument showed scratches and marks/abrasions during visual inspection.Additional patient demographic information: body mass index (bmi) of 21.6 kg/m2.

• 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: 24016606
• Report Number: 2955842-2026-00518
• Device Sequence Number: 16098082
• Product Code: NAY
• UDI-Device Identifier: 00886874125588
• UDI-Public: (01)00886874125588(10)U10250715
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2026

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: U10250715 0105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/15/2025
• Supplement Date Received by Manufacturer: 01/16/2026
• Initial Report FDA Received Date: 01/08/2026
• Supplement Report FDA Received Date: 01/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/15/2025
• 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 Age: 43 YR
• Patient Sex: Female
• Patient Weight: 55 KG