MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC SINGLE-SITE; FENESTRATED BIPOLAR FORCEPS

Model Number	478093-03
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the tip of the fenestrated bipolar forceps (fbf) instrument broke and a fragment fell inside the patient.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 was inspected prior to use, and no damage was noted.The surgeon did not notice any issues with the functionality of the instrument during the surgical procedure.The instrument did not collide with any other instruments or other hard materials.The surgical staff did not feel any resistance upon removal of the instrument through the cannula.There was no damage to the cannula.The fragment was retrieved during the same procedure, and the area was visually inspected.No additional surgical procedure was required to remove the fragment.There were no postoperative tests, such as an x-ray or ultrasound, performed.The patient has not returned to the hospital due to experiencing any post-surgical complications.The instrument will be returned for evaluation.
Additional Manufacturer Narrative
The fbf instrument has not been received for failure analysis evaluation.
Additional Manufacturer Narrative
Updated fields: d9, h2, h3, h6, and h11.Device evaluation: intuitive surgical, inc.(isi) received the fenestrated bipolar forceps instrument to perform failure analysis.The instrument was analyzed and found to have one severely bent grip, causing misalignment of the grip-tips.There was a 0.053" offset at the tips.There were no missing pieces.
Event or Problem Description
Refer to h11 for follow-up information.

• Brand Name: SINGLE-SITE
• Common Device Name: 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: 22917138
• Report Number: 2955842-2025-36003
• Device Sequence Number: 18615188
• Product Code: NAY
• UDI-Device Identifier: 10886874113735
• UDI-Public: (01)10886874113735(17)270228(10)K10250220
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K130726
• 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
• Report Date (Section B): 02/26/2026

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: 478093-03
• Device Catalogue Number: 478093
• Device Lot Number: K10250220
• 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: 08/07/2025
• Supplement Date Received by Manufacturer: 02/03/2026
• Initial Report FDA Received Date: 08/28/2025
• Supplement Report FDA Received Date: 02/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/20/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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