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

Model Number 470361-08

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/25/2023

Event Type  Injury  

Event Description

It was reported that during a da vinci-assisted surgical procedure, the fragments of the cannula or cannula seal fell into the cavity of the patient.The defective product was from another company, therefore no product is being returned.There was no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the cannula seal had no physical damage.The fragment that fell into the patient was confirmed to be a third-party product.It was unknown what the cause of the fragment falling into the patient.It was also noted that it was unknown if the fragment was retrieved and if post-operative tests were performed.

Manufacturer Narrative

Based on the claim against the product by the customer noting fragment fell, an investigation was completed to determine the cause of this reported event.The fragment that fell into the patient was confirmed to be a third-party product, therefore no product is being returned for intuitive surgical, inc.(isi) evaluation.This is a reportable event due to the following conclusion: it was alleged that the instrument broke and a fragment fell inside the patient during a da vinci-assisted procedure.At this time, it is unknown what caused the breakage to occur.

• Brand Name: NONE
• Type of Device: 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: 16973209
• MDR Text Key: 315760512
• Report Number: 2955842-2023-14473
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 10886874112547
• UDI-Public: (01)10886874112547(10)M12220820
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K133845
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 04/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 470361-08
• Device Catalogue Number: 470361
• Device Lot Number: M12220820
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES