MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC NONE

Model Number	430073-02
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A return material authorization (rma) was issued to evaluate the intuitive surgical, inc.(isi) device.A follow-up mdr will be submitted if the product is returned and evaluated and/or if additional information is received.The provided image was reviewed by an intuitive surgical, inc.(isi) failure analysis engineer (fae) and it was stated that the access port itself does not appear to enter the patient.It appears one of the latching mechanisms of the access port broke and the access port separated from the wound retractor.The provided image was further reviewed by an isi clinical development engineer (cde).The fragment appeared to be from the tab on the access port that would help secure the access port to the wound retractor.This part was external to the patient and from what was gathered from the image, it appears to be mostly intact.
Event or Problem Description
It was reported that during a da vinci-assisted cholecystectomy surgical procedure, after installing the access port kit and injecting carbon dioxide (co2), a popping sound was heard and the fragments flew off.The user stopped using it and retrieved the pieces during the same procedure.There was no patient injury.The access port kit was removed and replaced with a backup.The procedure was completed as planned with no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained additional information on 30-sep-2024: the reporter confirmed that the issue occurred during a c02 insufflation and a third-party device was used for the insufflation.The reporter confirmed that the insufflation gas was supplied through gas canisters.The gas source was checked prior to use.The instruments and access port kit were inspected prior to use.The reporter confirmed that the white connection part was damaged.It was confirmed that fragment fell outside of the patient.The user replaced the access port kit and continued and completed the procedure as planned.
Event or Problem Description
Refer to h11 for follow-up information.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis and the complaint was confirmed.The access port kit was found to have a broken housing tab of the chamber portion of the access port.

• Brand Name: NONE
• Common Device Name: NONE
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer Contact: izabel nielson ; 3410 central expressway; santa clara, CA 95051 ; 4085232100
• MDR Report Key: 20458559
• Report Number: 2955842-2024-20700
• Device Sequence Number: 8701710
• Product Code: NAY
• UDI-Device Identifier: 10886874119546
• UDI-Public: (01)10886874119546(17)251231(10)U80231207
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K202571
• 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): 09/18/2024

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: 430073-02
• Device Catalogue Number: 430073
• Device Lot Number: U80231207
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/18/2024
• Supplement Date Received by Manufacturer: 10/19/2024
• Initial Report FDA Received Date: 10/16/2024
• Supplement Report FDA Received Date: 11/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/07/2023
• 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: Prefer Not To Disclose