MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DA VINCI; CANNULA SEAL

Model Number	470361-08
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted gynecology surgical procedure, the closing valve of the cannula did not hold and generated gas leaks (co2).The procedure was converted to laparoscopic surgery with no reported injury.Intuitive surgical inc.(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
An investigation is in progress to determine the cause of this reported event.A return material authorization (rma) was issued to the customer requesting to have the intuitive device returned.However, isi has not received the product involved with the alleged issue to perform failure analysis.Additional information is being gathered to determine the contribution of the device to the customer reported issue.A follow-up mdr will be submitted if the product is returned (post failure analysis evaluation) or if additional information is received.
Event or Problem Description
Refer to h10/h11 for follow-up information.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the da vinci product to perform failure analysis.The cannula seal was analyzed, and failure analysis investigations did not replicate nor confirm the customer reported complaint.The cannula seal was inspected and found to have physical damage.The gravity test was performed on the stopcock and passed.The stopcock remained static in the top position.No product issue was identified.

• Brand Name: DA VINCI
• Common Device Name: CANNULA SEAL
• 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: 17704320
• Report Number: 2955842-2023-18297
• Device Sequence Number: 6746510
• Product Code: GCJ
• UDI-Device Identifier: 10886874112547
• UDI-Public: (01)10886874112547(10)M14230217
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K133845
• 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,Followup
• Report Date (Section B): 08/17/2023

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: 470361-08
• Device Catalogue Number: 470361
• Device Lot Number: M14230217
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/17/2023
• Supplement Date Received by Manufacturer: 09/21/2023
• Initial Report FDA Received Date: 09/07/2023
• Supplement Report FDA Received Date: 10/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/17/2023
• 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: Female