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

Model Number	400077-04
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The intuitive surgical inc.Failure analysis team replicated/confirmed the customer reported complaint.The cannula seal was found to have torn material measuring 0.083" x 0.046" in size that was not returned.The root cause of the ¿tears/torn seals¿ is most commonly attributed to mishandling/misuse.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, pieces from the cannula seal broke off and fell inside the patient's abdomen.The surgeon was able to retrieve all fragments during the same procedure.The customer replaced the cannula seal with a back-up accessory of the same kind and completed the procedure with no reported injury.Intuitive surgical, inc.Has made multiple follow-up attempts to obtain additional information.However, no further details have been received as of the date of this report.

• Brand Name: NONE
• 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: 16928119
• Report Number: 2955842-2023-13541
• Device Sequence Number: 6899776
• Product Code: NAY
• UDI-Device Identifier: 00886874110997
• UDI-Public: (01)00886874110997(10)NA
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 06/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 400077-04
• Device Catalogue Number: 400077
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/08/2021
• Initial Report FDA Received Date: 05/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/15/2011
• 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