MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC SINGLE-SITE; FUNDUS GRASPER

Model Number	478058-04
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	02/17/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the connecting part of the fundus grasper tip was broken, and a fragment fell into the patient.The fragment was removed during the same procedure.The procedure was completed.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 surgical task being performed when the device fragment fell into the patient was instrument removal.It is unknown what the surgeon believes was the cause of the instrument breakage.The instrument was in use for about 15 to 20 minutes.The surgeon did not notice any issue with the functionality of the instrument during the procedure prior to the breakage.The instrument did not collide with any other instruments or other hard materials during the surgical procedure.The fragment did not fall inside the patient during an instrument tip collision.The instrument was not removed during the surgical procedure prior to the breakage.Upon final removal of the instrument, the wrist was straightened.The staff did not feel any resistance upon the final removal of the instrument through the cannula.There was no damage to the cannula or other damage to the instrument after the event occurred.The fragment was retrieved during the same procedure, and it was visually confirmed that there were no remaining fragments.No additional surgical procedure was required to remove the fragments.No post-operative tests, such as an x-ray or ultrasound, were performed to check for remaining fragments.The procedure was completed robotically.The patient did not return to the hospital due to experiencing any post-surgical complications related to retaining a foreign object.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive the da vinci product with an alleged issue, but the failure analysis evaluation has not been completed.The event investigation is in progress.
Event or Problem Description
Refer to h11 for follow-up information.
Additional Manufacturer Narrative
Updated sections, d9, h3, annex codes: c, d.Device evaluation: an investigation was completed to determine the cause of this reported event.Intuitive surgical, inc.(isi) received the single-site fundus grasper instrument to perform failure analysis (fa) and was able to confirm and replicate the customer reported complaint.During the visual inspection, the instrument was found to have a broken distal clevis.As a result, one of the grips was completely detached from the instrument.The broken pieces were returned with the instrument.The clevis does not show abrasions or scratches on the outer surface.Components adjacent to the broken clevis do not show damage.

• Brand Name: SINGLE-SITE
• Common Device Name: FUNDUS GRASPER
• 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: 21593133
• Report Number: 2955842-2025-05714
• Device Sequence Number: 20920178
• Product Code: NAY
• UDI-Device Identifier: 00886874113622
• UDI-Public: (01)00886874113622(11)230720(10)K10230720
• 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,Followup
• Report Date (Section B): 02/17/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 478058-04
• Device Catalogue Number: 478058
• Device Lot Number: K10230720 0034
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/17/2025
• Supplement Date Received by Manufacturer: 03/25/2025
• Initial Report FDA Received Date: 03/13/2025
• Supplement Report FDA Received Date: 04/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/20/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown