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

Model Number	420142-09
Medical Device Problem Code	Arcing (2583)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted radical tonsillectomy surgical procedure, there was arcing on the tip of monopolar cautery instrument.Post the arcing event, it was found that the instrument had burn signs.There was no grounding location for the arcing, as it could be seen while in air.The procedure was completed with no reported injury.
Additional Manufacturer Narrative
Based on the claim against the product noting arcing event, an investigation is in progress to determine the cause of this reported.Additional information is being gathered to determine the contribution of the device to the customer reported issue.A review of the provided image was performed by an intuitive surgical, inc.(isi) failure analysis engineer.The following additional information was provided: the monopolar cautery instrument does appear to have some discoloration at the distal end.It is difficult to tell for sure from the image, but the instrument tube adapter may have damage at the distal tip.In order to determine the root cause the instrument will need to be returned.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the monopolar cautery instrument with an alleged issue to perform failure analysis and the customer reported complaint was replicated/confirmed.Failure analysis found the primary failure of thermal damage to the tube adapter to be related to the customer reported complaint.During visual inspection, the instrument was found to have thermal damage at the tip the adapter.The instrument was placed and driven on an in-house system.The instrument passed the recognition and engagement tests.The setting used on the generator was 50 for cutting and 50 for coagulation.The instrument released energy and began arcing almost immediately on several attempts.Inspection of the adapter showed the tip was burned and melted.
Event or Problem Description
Refer to h10/h11 for follow-up information.

• Brand Name: ENDOWRIST
• Common Device Name: MONOPOLAR CAUTERY
• 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: 17091977
• Report Number: 2955842-2023-16071
• Device Sequence Number: 20376520
• Product Code: NAY
• UDI-Device Identifier: 00886874119136
• UDI-Public: (01)00886874119136(10)T10201207
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K050369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2023

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: 420142-09
• Device Catalogue Number: 420142
• Device Lot Number: T10201207 591
• 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: 05/13/2023
• Supplement Date Received by Manufacturer: 08/15/2023
• Initial Report FDA Received Date: 06/08/2023
• Supplement Report FDA Received Date: 09/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/09/2020
• 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