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

Model Number	478055-04
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation was completed to determine the cause of this reported event.Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The cadiere forceps instrument was analyzed and found to have a completely broken grip tip.A piece approximately 1.0310" x 0.2390" was found to be broken off.The broken piece was returned.Components adjacent to this broken grip show damage.The instrument was found to have a broken distal clevis at the base of the clevis.The broken pieces were not returned, measuring roughly 0.3705¿ x 0.2230¿ in size.Clevis does not show abrasions or scratches on the outer surface.Components adjacent to the broken clevis do show damage.The grip pin is dislodged and grip tip broken.The grip pin is dislodged as a result of completely broken grip tip.The pin is returned.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.Grip tip fragments may result when the metal injection molding (mim) is not retained to the overmold (om) during use.This issue can be resolved by using an alternate instrument to complete the procedure.
Event or Problem Description
It was reported that during a da vinci-assisted myomectomy surgical procedure, the 8mm cadiere forceps instrument's tip broke while grasping uterine tissue.It had 6 uses remaining.No fragment fell into the patient.The procedure was completed with no reported injury.

• Brand Name: SINGLE-SITE
• Common Device Name: CADIERE 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: 22866696
• Report Number: 2955842-2025-35180
• Device Sequence Number: 9230629
• Product Code: NAY
• UDI-Device Identifier: 00886874113608
• UDI-Public: (01)00886874113608(11)240530(10)K10240530
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K152448
• 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
• Report Date (Section B): 08/08/2025

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: 478055-04
• Device Catalogue Number: 478055
• Device Lot Number: K10240530 0015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/08/2025
• Initial Report FDA Received Date: 08/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/30/2024
• 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: Reuse
• 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: Unknown