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

Model Number	478093-03
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The fenestrated bipolar forceps instrument has not been received for failure analysis evaluation.
Event or Problem Description
It was reported that during a da vinci-assisted hysterectomy surgical procedure, the tip of the fenestrated bipolar forceps instrument detached; the surgery was immediately continued after replacing it with a backup instrument.A fragment fell into the patient and was retrieved during the same procedure; the detached tip was removed immediately, all visually identifiable fragments were removed (1 fragment), and the patient showed no abnormalities.The procedure was delayed for approximately 5 minutes for instrument replacement and fragment removal.There was no bleeding and no patient abnormalities.The fragment removal was completed and enclosed.The procedure was completed.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the instrument used during the surgical procedure was inspected before use, with no damage or abnormalities observed at that time.During the surgery, a device fragment unexpectedly fell inside the patient; however, there was no evidence of instrument collision or accessory tip impact that could have caused the issue.The precise surgical task ongoing when the fragment fell, as well as the surgeon's opinion about the cause of the breakage and the duration of instrument use prior to the incident, were not specified in the available information.The instrument did not collide with other instruments or hard materials.The fragment(s) were retrieved during the same surgery, confirmed by visual inspection, and no additional surgical intervention was needed.The operation was successfully completed robotically, without any additional injury to the patient, and the patient has not required further hospital visits for related complications.The instrument and associated accessories are available for return to isi for evaluation, though photographic images or procedural videos were not available for review.

• 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: 25172302
• Report Number: 2955842-2026-24869
• Device Sequence Number: 18687658
• Product Code: NAY
• UDI-Device Identifier: 00886874113738
• UDI-Public: (01)00886874113738(17)270228(10)K10250213
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 05/14/2026

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: K10250213 0037
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/23/2026
• Initial Report FDA Received Date: 05/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/13/2025
• 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