MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC SINGLE-SITE; PERMANENT CAUTERY HOOK

Model Number	478090-03
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did not receive the da vinci product with an alleged issue to perform failure analysis.Review of the provided image is consistent with complaint regarding the broken white plastic tip.Root cause of the failure mode cannot be confirmed without the returned device.No further escalations required for the image review.Blank mdr fields: the missing patient information in sections a and b was either unknown, unavailable, not provided, or not applicable.The expiration date for section d4 is not applicable.Field d6 is blank because the product is not implantable.Information for the blank fields in section e1 is not available.Fields g5 and g7 are not applicable.
Event or Problem Description
It was reported that during central processing, user noticed that the plastic part wrapping the hook tip was broken after 3 uses.There was no report of patient involvement or patient injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained additional information: the reporter confirmed that the statement "plastic part wrapping around the instrument's tip" referred to the white distal tip.The issue of damaged conductor wire was identified during inspection prior to sterilization packaging, after being dispensed from the washer.During the reprocessing of the instrument, no damage was found during the initial inspection before preliminary cleaning, but it was not checked after preliminary cleaning and before being placed in the washer, suggesting that the damage might have occurred during preliminary cleaning or the washing process.The white tip was confirmed to have broken off and detached from the instrument.During the last use in surgery, the instrument was inspected before use, and no damage or anything out of the ordinary was noted.No fragment fell into the patient, and thus no retrieval or additional surgical procedure was required.No post-operative tests like x-ray or ultrasound were performed, and there was no injury to the patient.It was confirmed that the instrument did not collide with any other instruments or hard material during the surgical procedure.
Additional Manufacturer Narrative
The instrument was found have a broken distal clevis at the base of the cautery hook.The broken piece was not returned, measuring roughly 0.0630¿ x 0.0485¿ in size.Common causes of the failure mode broken instrument ceramic sleeve are attributed to damage during use, which may result from applying excess force on the instrument tip during handling, insertion, usage (overloading), or removal.Instrument collisions with other hand-held instrumentation or instrument driven outside the field of view can also cause damage to the instrument distal clevis.
Event or Problem Description
Refer to h11 for follow-up information.

• Brand Name: SINGLE-SITE
• Common Device Name: PERMANENT CAUTERY HOOK
• 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: 22684139
• Report Number: 2955842-2025-32530
• Device Sequence Number: 15740596
• Product Code: NAY
• UDI-Device Identifier: 00886874113721
• UDI-Public: (01)00886874113721(11)250109(10)K10250109
• 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,Health Professional
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2025

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: 478090-03
• Device Catalogue Number: 478090
• Device Lot Number: K10250109 0003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/10/2025
• Supplement Date Received by Manufacturer: 09/24/2025
• Initial Report FDA Received Date: 08/01/2025
• Supplement Report FDA Received Date: 10/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/09/2025
• 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