MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST;DAVINCI SI; PERMANENT CAUTERY HOOK

Model Number	420183-15
Medical Device Problem Code	Arcing (2583)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted liver resection surgical procedure, the permanent cautery hook instrument had an electrical leakage.The user completed the procedure using a backup permanent cautery hook with no further issue reported.No fragment fell inside the patient.No known impact or patient consequence was reported.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) has requested the site to return the da vinci product involved in this complaint to perform failure analysis.At the time of this report, the product has not been received.Additional information is being gathered to determine the contribution of the device to the customer reported issue.Image(s) associated with this reported event were submitted for review.A review of the provided image was performed by an intuitive surgical, inc.(isi) failure analysis engineer.The following additional information was provided: the instrument has thermal damage to the monopolar yaw pulley near the ceramic sleeve.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The permanent cautery hook (pch) instrument was analyzed and found to have thermal damage on the monopolar yaw pulley.The thermal damage was found at the top of the yaw pulley below the sleeve.The instrument was placed and driven on an in-house system.The instrument delivered energy with signs of arcing on 3 of 3 attempts.Components adjacent to the yaw pulley show thermal damage.The complaint was confirmed by failure analysis.
Event or Problem Description
Refer to h10/h11 for follow-up information.

• Brand Name: ENDOWRIST;DAVINCI SI
• 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: 19378260
• Report Number: 2955842-2024-14878
• Device Sequence Number: 18068378
• Product Code: NAY
• UDI-Device Identifier: 00886874111536
• UDI-Public: (01)00886874111536(10)K10220904
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K050369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2024

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: 420183-15
• Device Catalogue Number: 420183
• Device Lot Number: K10220904 851
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/28/2024
• Supplement Date Received by Manufacturer: 07/26/2024
• Initial Report FDA Received Date: 05/22/2024
• Supplement Report FDA Received Date: 08/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2022
• 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: Prefer Not To Disclose