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

Model Number	470361-08
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	06/30/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted gastric bypass surgical procedure, a cannula seal was broken off in the tubing, causing a loss of pneumoperitoneum.The broken piece had to be retrieved from the insufflation tubing to re-establish pneumoperitoneum.The procedure was completed with no reported injury.Intuitive surgical inc.(isi) followed up with the initial reporter and obtained the following additional information: the stopcock feature of the universal seal was able to maintain pneumoperitoneum after the issue was identified.There was no loss of vision or instrument control, and no significant delay was noticed.The issue was identified during a gastric procedure.The instrument was inspected, and no abnormality or damage noted.The instrument was in use prior to the issue for 30 minutes.There were no fragments that fell into the patient during a collision.Fragments were retrieved by crile clamp used to grasp piece.All fragments were retrieved through visual inspection.No additional procedure or x-rays performed to remove fragments.The case was completed, and insufflation was transferred to another port.There was no injury to the patient.The patient had not returned to the hospital.
Additional Manufacturer Narrative
Based on the claim against the product by the customer noting port broke off in the tubing an investigation is in progress to determine the cause of this reported event.Similar event occurred with another universal seal during same procedure (patient identifier #: b)(6)).Additional information is being gathered to determine the contribution of the device to the customer reported issue.Image review: review of the provided image is not consistent with reported complaint.No conclusion could be derived based upon provided image.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received a da vinci product to perform failure analysis.The seal was analyzed and the reported failure was confirmed.The seal was found to have the luer fitting broken.The size of the broken piece measures approximately 0.289" x 0.385".The broken piece was returned.
Event or Problem Description
Refer to h10/h11 for follow-up information.

• 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: 17465744
• Report Number: 2955842-2023-17526
• Device Sequence Number: 2905025
• Product Code: GCJ
• UDI-Device Identifier: 10886874112547
• UDI-Public: (01)10886874112547(10)NA
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 07/05/2023

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/05/2023
• Supplement Date Received by Manufacturer: 08/24/2023
• Initial Report FDA Received Date: 08/04/2023
• Supplement Report FDA Received Date: 09/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/10/2018
• 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 Age: 42 YR
• Patient Sex: Female
• Patient Weight: 131 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White