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

Model Number	470380-08
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/16/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a da vinci-assisted low anterior resection (lar) surgical procedure, a fragment of the cannula seal fell into the patient¿s anatomy.The fragment was a result of a portion of the cannula seal valve being broken off.The customer confirmed that the fragment was removed during the same procedure, and no more residue was left inside the patient¿s anatomy.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 cannula seal was not inspected prior to use since it is a disposable product.The cannula seal did not collide with any other instrument or hard material during the surgical procedure.The fragment was retrieved by using the other instrument during the same procedure.Visual inspection confirmed that all fragments were retrieved.No additional procedure was required to remove the fragment.No post-operative tests were performed.The procedure was completed robotically with no patient injury.The patient did not return to the hospital due to any post-surgical complications.
Additional Manufacturer Narrative
Based on the claim against the product by the customer noting a broken cannula seal and a fragment fell inside the patient, an investigation was completed to determine the cause of this reported event.Intuitive surgical, inc.(isi) received the cannula seal involved with this complaint and completed the device evaluation.Failure analysis (fa) investigation confirmed the customer reported complaint.The cannula seal accessory was analyzed and found that the duckbill of the cannula seal was torn.The torn piece of was returned with the cannula seal.The complaint regarding the broken cannula seal was confirmed by failure analysis, which indicated that the device did contribute to the customer reported issue.The probable root cause of the reported issue is attributed to damage during various handling points, including manufacturing, installation, or use.This issue can be resolved by using an alternate accessory to complete the procedure.

• Brand Name: NONE
• Common Device Name: 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: 17079941
• Report Number: 2955842-2023-16004
• Device Sequence Number: 16691370
• Product Code: NAY
• UDI-Device Identifier: 10886874112578
• UDI-Public: (01)10886874112578(10)M11221102
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K140553
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 05/16/2023

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: 470380-08
• Device Catalogue Number: 470380
• Device Lot Number: M11221102 10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/16/2023
• Initial Report FDA Received Date: 06/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/26/2022
• 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