MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DAVINCI XI; SEAL,IS4000 PORTS,5MM-8MM,BOX OF 10

Model Number	470361
Medical Device Problem Code	Gas/Air Leak (2946)
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
An investigation was completed to determine the cause of this reported event.The reported event was addressed with phone support.The customer replaced cannula seal to resolve reported issue.No site visit was conducted.The system was working properly, and no additional action was required as the issue was resolved.
Event or Problem Description
It was reported that during a da vinci-assisted umbilical hernia surgical procedure, the cannula seal broke releasing insufflation while driving a needle instrument.The customer replaced the cannula seal to continue with the procedure.The intuitive surgical, inc.(isi) technical service engineer (tse) recommended the customer return the cannula seal for failure analysis.The site was completing the procedure as planned with no reported injury.
Additional Manufacturer Narrative
Intuitive surgical inc.(isi) followed up and obtained additional information.The customer pulled out the cannula and started a new cannula.The insufflation was minimal.No patient injury and no harm and no return of patient for additional procedures.
Event or Problem Description
Refer to h10/h11 for follow-up information.

• Brand Name: DAVINCI XI
• Common Device Name: SEAL,IS4000 PORTS,5MM-8MM,BOX OF 10
• 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: 18927682
• Report Number: 2955842-2024-12558
• Device Sequence Number: 4580218
• Product Code: NAY
• UDI-Device Identifier: 00886874112540
• UDI-Public: 00886874112540
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K133845
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2024

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: 470361
• Device Catalogue Number: 470361
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/22/2024
• Supplement Date Received by Manufacturer: 03/19/2024
• Initial Report FDA Received Date: 03/19/2024
• Supplement Report FDA Received Date: 04/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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