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	Insufficient Information (4580)
Date of Event	04/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted myomectomy surgical procedure, the tip of the 8mm permanent cautery hook instrument was broken.The instrument was removed and replaced with a backup.Following this, the user continued and completed the procedure with no further issues.No fragment fell into the patient.No known impact or patient consequence was reported.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained additional information: the user confirmed that the tip was broken but not detached.No fragment fell into the patient and there was no patient injury.There was no post-operative tests performed.There was no report of post-surgical complications and the patient has not returned to the hospital.The instrument did not collide with any other instruments or hard materials during the procedure.No images or videos are available for isi review.The reporter was unable to disclose the patient demographic information.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the 8 mm permanent cautery hook instrument to perform failure analysis.The instrument was analyzed and found to have a completely broken main tube at the distal assembly.The cautery wire is hanging.The instrument failed the continuity test.No material was found missing.Components adjacent to this broken main tube do show damage.The conductor wire dislodged.Additional observation(s) related to customer complaint: the instrument was found to have a broken conductor wire at the distal.The conductor wire was broken and failed the continuity test.

• 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: 22392072
• Report Number: 2955842-2025-28777
• Device Sequence Number: 18407140
• Product Code: GCJ
• UDI-Device Identifier: 00886874113721
• UDI-Public: (01)00886874113721(11)240111(10)K10240111
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 06/27/2025

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: K10240111 0041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/27/2025
• Initial Report FDA Received Date: 07/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/11/2024
• 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