MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC NONE; CANNULA SEAL

Model Number	400077-04
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the cannula seal involved with this complaint and completed the device evaluation.Failure analysis did not replicate nor confirm the reported complaint.Visual inspection did not reveal any damage.No product issue was identified.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, at the time an instrument was installed, the site observed a broken valve in the cannula seal and an alleged air leak occurred.The procedure was completed with no reported injury.

• Brand Name: NONE
• Common Device Name: CANNULA SEAL
• 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: 20338335
• Report Number: 2955842-2024-19856
• Device Sequence Number: 8108343
• Product Code: NAY
• UDI-Device Identifier: 10886874110994
• UDI-Public: (01)10886874110994(17)270930(10)K10230921
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 09/02/2024

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: 400077-04
• Device Catalogue Number: 400077
• Device Lot Number: K10230921
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/02/2024
• Initial Report FDA Received Date: 09/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/21/2023
• 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: Prefer Not To Disclose