MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC NONE; CAUTERY SPATUAL TIP

Model Number	400160-05
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Intuitive surgical, inc.(isi) received the cautery spatula tip (tip) as a discrepant rma along with the product returned under patient identifier (b)(6).There was no alleged malfunction or patient injury reported against this product.Isi made multiple follow-up attempts to obtain additional information.However, no further details have been received as of the date of this report.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the cautery spatula tip (tip) as an unrequested rma.Although there was no alleged malfunction reported against this product, an investigation was completed.Visual inspection of the accessory found thermal damage at the proximal tip (located at the bottom).The tip exhibited signs of charring and melting, which is indicative of arcing from the instrument that was used when the accessory was installed.No piece was found to be missing.

• Brand Name: NONE
• Common Device Name: CAUTERY SPATUAL TIP
• 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: 17955164
• Report Number: 2955842-2023-19328
• Device Sequence Number: 5020722
• Product Code: NAY
• UDI-Device Identifier: 10886874111038
• UDI-Public: (01)10886874111038(10)NA
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K050369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 09/20/2023

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: 400160-05
• Device Catalogue Number: 400160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/20/2023
• Initial Report FDA Received Date: 10/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/03/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• 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