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

Model Number	420183-11
Medical Device Problem Code	Arcing (2583)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2024
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 (pch) instrument was analyzed and found to have thermal damage to the monopolar yaw pulley near the yaw pulley and conductor wire interface.Thermal damage was likely a result of the broken conductor wire at the weld.The material appeared to have burnt off from the charring that occurred near the conductor wire.The components adjacent to the yaw pulley showed thermal damage.When cutting the clevis ear for inspection, the weld of the yaw pulley had the yaw cable snapped.Further investigation after cutting the clevis ear noted the instrument had a broken conducted wire.The pch instrument failed the electrical continuity test.There were no signs of thermal damage.In addition, the pch instrument was found to have damage at the conductor wires insulation at the weld.There was no material missing and the conductor wire was exposed.The conductor wire insulation was damaged, and the wire was fully broken.The thermal damage to the yaw pulley and conductor wire cap were the affected adjacent components.Thermal damage was also found on the pch instrument conductor cap.A grip cable was also found derailed from its normal position at the distal idler pulley.The instrument passed the intuitive motion test.The test was performed before cutting the clevis ear to inspect the weld of the yaw pulley.A visual inspection of the back end, found no evidence of a cracked clamping pulley, input disk, or input shaft that would have caused the loose cable.The complaint was confirmed by failure analysis.
Event or Problem Description
It was reported that during a da vinci-assisted pulmonary lobectomy surgical procedure, the permanent cautery hook (pch) instrument had a leakage.The procedure was completed with a backup pch instrument and with no further issue reported.There was no known impact or patient consequence reported.Isi followed up with the initial reporter and obtained the following additional information: the reporter confirmed that there was no electrical discharge.The instrument was inspected before use and there was no damage or anything out of the ordinary.The reporter confirmed that no arcing was observed.Additionally, the reporter confirmed that the instrument's tips did not collide with any other instruments or tools during the procedure.There was no patient injury.There was no report of post-surgical complication and the patient did not returned to the hospital.No images or videos are available.

• Brand Name: ENDOWRIST;DAVINCI SI
• Common Device Name: PERMANENT CAUTERY HOOK
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA
• Manufacturer Contact: izabel nielson ; 3410 central expressway; santa clara, CA ; 4085232100
• MDR Report Key: 19140620
• Report Number: 2955842-2024-13258
• Device Sequence Number: 15305306
• Product Code: NAY
• UDI-Device Identifier: 00886874111536
• UDI-Public: (01)00886874111536(10)N10171218
• 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
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 03/27/2024

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: 420183-11
• Device Catalogue Number: 420183
• Device Lot Number: N10171218 527
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/15/2017
• 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