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 Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the claim against the product by the customer noting that a fragment from the cannula seal fell inside the patient, an investigation is in progress to determine the cause of this reported event.Additional information is being gathered to determine the contribution of the device to the customer reported issue.The cannula seal has been requested to be returned for failure analysis investigation.As of the date of this report, the product has not yet been returned.Based on the information available at this time, this complaint is being classified as a reportable event due to the following conclusion: it was alleged that the cannula seal broke and a fragment fell inside the patient during a da vinci assisted procedure.The fragment was retrieved during the same procedure with no patient injury.At this time, it is unknown what caused the breakage to occur.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, an unknown fragment was found inside the patient's anatomy and retrieved immediately upon being seen.It was found that the unknown fragment was part of the silicon for the 8mm cannula seal.The procedure was completed using a backup cannula seal with no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the fragment of the cannula seal was retrieved during the same procedure.It was confirmed visually that all the fragments were removed.There was no additional surgical procedure or post-operative tests performed regarding the removed fragment.It was unknown how long the cannula seal was in use for prior to the issue, and the surgeon does not know what the cause could have been.The cannula seal was inspected prior to use and there was no damage or anything out of the ordinary.The surgeon did not notice any functionality issues.The surgeon did not know exactly how the fragment fell inside the patient.
Event or Problem Description
Refer to h10/h11 for follow-up information.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received a da vinci product (cannula seal) to perform failure analysis; however, failure analysis could not verify the external event.During visual inspection, there was no broken pieces or damage found.No product issue was identified.The accessory was visually inspected and the failure analysis investigations revealed no issues related to the customer reported event.The source of the reported fragment remains unknown.

• 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: 16144997
• Report Number: 2955842-2023-10038
• Device Sequence Number: 6867076
• Product Code: NAY
• UDI-Device Identifier: 10886874110994
• UDI-Public: (01)10886874110994(10)M90220518
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K050369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2022

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: M90220518
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/13/2022
• Supplement Date Received by Manufacturer: 05/02/2023
• Initial Report FDA Received Date: 01/12/2023
• Supplement Report FDA Received Date: 06/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/18/2022
• 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