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

Model Number	478093-03
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive the single site fenestrated bipolar forceps instrument to perform failure analysis.During the visual inspection, the instrument was found to have a broken grip that was completely detached from its base, and it was only holding on by the conductor wire.The broken piece was hanging from the instrument.The distal clevis was also found to be broken.Missing pieces were not returned with the instrument.The probable root cause is attributed to damage during use, which may result from an accidental drop of the instrument or inadvertent collisions with other instruments or hard surfaces.
Event or Problem Description
It was reported that during a da vinci-assisted benign hysterectomy surgical procedure, the tip was broken on a single site fenestrated bipolar forceps instrument.No fragment fell into the patient.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) contacted the initial reporter and obtained the following information: the customer stated that no fragment fell into the patient and the patient has not returned to the hospital due to any post-surgical complications related to this issue.
Additional Manufacturer Narrative
Correction to h8 field - updated to initial use of device the probable root cause of the failure mode broken instrument grips -tips, broken distal clevis and detached fragment is attributed to use conditions.It includes damage from applying excessive force on the instrument shafts or tips during handling, insertion, usage, or removal.
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: 21501667
• Report Number: 2955842-2025-04160
• Device Sequence Number: 4501272
• Product Code: NAY
• UDI-Device Identifier: 10886874113735
• UDI-Public: (01)10886874113735(17)260531(10)K10240509
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/14/2025

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: K10240509 0036
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/04/2025
• Supplement Date Received by Manufacturer: 11/20/2025
• Initial Report FDA Received Date: 03/03/2025
• Supplement Report FDA Received Date: 12/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/09/2024
• 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