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

Model Number	420183-16
Medical Device Problem Code	Arcing (2583)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The permanent cautery hook was analyzed and reported failure was confirmed.After cutting the clevis ear off, the instrument was found to have a broken conductor wire at the weld.The instrument failed the electrical continuity test.There were signs of thermal damage.Additionally, the instrument was found to have damage of the conductor wire¿s insulation near the weld.There was no material missing and the conductor wires were exposed.The instrument failed the electrical continuity tests.Thermal damage to the yaw pulley and conductor cap and broken conductor wire are the affected adjacent components.The instrument was found to have thermal damage to the monopolar yaw pulley near the yaw pulley and conductor wire interface.Thermal damage is a result of the broken conductor wire at the weld.Material appears to have burnt off from the charring that occurred near the conductor wire.Components adjacent to the yaw pulley show thermal damage.The instrument was found to have thermal damage to the conductor cap.
Event or Problem Description
It was reported that during a da vinci-assisted pancreatoduodenectomy surgical procedure, when energy was applied, a small spark was produced around the permanent cautery hook instrument.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the customer to confirm that the instrument was inspected before use with no damage.There was no damage noticed to the instrument after the arcing event but there was a little smoke at the base of the tip.They observed that there was nothing strange inside and no damage was observed on the surface of the cannula.A pin gauge was not used to inspect the cannula.The surgeon was beginning to dissect, and it was on the first shot when the spark happened.The surgeon was using monopolar coagulation.The surgeon was using the third-party generator with the settings set at 30.The instrument was no more than 3 minutes inside.Because when the surgeon began to dissect, the event occurred, and the instrument was removed immediately.They were also using the fenestrated bipolar and cadiere instruments when the issue occurred.None of the instruments collided and the surgeon was about to touch the tissue when the spark occurred.The jaws were not immersed in liquid or contaminated by carbonized tissue (bio debris) prior to activating the instrument.There was no injury to the patient.
Event or Problem Description
Refer to h10/h11 for follow-up information.
Additional Manufacturer Narrative
The permanent cautery hook instrument was transferred to the failure analysis engineer team and the initial failure analysis findings were confirmed.Additional analysis was performed.A computed tomography (ct) scan of the monopolar yaw pulley was performed to examine the crimp and electrode inside.It was observed that the other end of the broken conductor wire piece was still attached to the electrode, indicating that it had been successfully crimped in place, but something caused the wire to pull out.

• Brand Name: ENDOWRIST
• 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: 19442710
• Report Number: 2955842-2024-14990
• Device Sequence Number: 8611546
• Product Code: NAY
• UDI-Device Identifier: 00886874111536
• UDI-Public: (01)00886874111536(10)K10230914
• Combination Product (Y/N): N
• Initial Reporter Country: EC
• PMA/510(K) Number: K050369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2024

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: 420183-16
• Device Catalogue Number: 420183
• Device Lot Number: K10230914 036
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/06/2024
• Supplement Date Received by Manufacturer: 07/30/2024
• Initial Report FDA Received Date: 06/01/2024
• Supplement Report FDA Received Date: 08/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/14/2023
• 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
• Patient Sex: Prefer Not To Disclose