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

Model Number	478093-03
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The single-site (ss) fenestrated bipolar forceps instrument was analyzed and found to have a broken proximal clevis at the ears of the clevis.The broken piece was returned, measuring roughly 8.09¿ x 5.00¿ in size.Clevis did not show abrasions or scratches on the outer surface.Components adjacent to the broken clevis do not show damage.The complaint was confirmed by failure analysis.The probable root cause is attributed to damage during use.Applying excessive force on the distal end of the instrument during handling, insertion, usage (overloading), or removal can cause damage.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the single-site (ss) fenestrated bipolar forceps instrument tip became open while suturing.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the customer confirmed that the jaws of the instrument were stuck open due to the jaw being loose.The instrument was removed and checked, and the tip did not fit, and the tip part was loose.The customer tried to align the jaw, but it wouldn't fit, so they stopped using it to prevent to fall the tip inside body.The issue did not result in the cannula being removed with the instrument.

• 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: 24014562
• Report Number: 2955842-2026-00530
• Device Sequence Number: 10591304
• Product Code: NAY
• UDI-Device Identifier: 10886874113735
• UDI-Public: (01)10886874113735(17)270228(10)K15250220
• 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: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 01/08/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 478093-03
• Device Catalogue Number: 478093
• Device Lot Number: K15250220 0050
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/16/2025
• Initial Report FDA Received Date: 01/08/2026
• 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
• Patient Sex: Female