MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ION; CATHETER

Model Number	490105-31
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	01/18/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the claim against the product by the customer noting piece dislodged, 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.Isi has received the catheter involved with this complaint; however, the evaluation is not completed yet.Therefore, the root cause of the alleged customer reported failure mode has not been determined.A follow-up mdr will be submitted upon completion of the failure analysis evaluation and if additional information is received.This complaint is considered a reportable malfunction event due to the following conclusion: it was alleged that a piece dislodged inside the catheter, the customer tried to remove but it was just stuck inside the catheter during a da vinci assisted procedure.At this time it is unknown what caused the piece to become dislodged.While there was no harm or injury to the patient, the reported failure mode could likely cause or contribute to an adverse event if it were to recur.Blank mdr fields: follow-up was attempted, but the missing patient information in sections a and b was either unknown, unavailable, not provided, or not applicable.The expiration date for section model # is not applicable.Field implant date is blank because the product is not implantable.
Event or Problem Description
It was reported that during an ion endobronchial lung biopsy procedure, the customer noticed a piece dislodged inside the catheter, it did not go inside the patient.The customer tried to remove but it was just stuck inside the catheter.The diagnostic procedure was completed with no reported injury.An intuitive surgical, inc.(isi) made multiple follow-up attempts to obtain additional information.However, no further details have been received as of the date of this report.
Additional Manufacturer Narrative
Intuitive has received the catheter associated with this complaint and completed investigations.Failure analysis investigations confirmed the customer reported complaint.Failure analysis found the primary failure of torn liner to be related to the customer reported complaint.The in-house zibra vision probe was inserted through the shaft for inspection and the id (internal diameter) was found to have a torn liner.The torn liner measured approximately 5.5 mm from the distal tip.The liner damage was visible when an external visual inspection of the distal tip was performed.The torn liner was still intact with the rest of the internal liner and no missing pieces were observed.The root cause of this failure is typically attributed to mishandling/misuse.Failure analysis found the secondary failure of failed continuity test to be related to the customer reported complaint.As a result of the liner damage, the continuity leak test was performed and failed with a leakage too high reading.The catheter was retested and failed during full test on both attempts.The od (out diameter) test was performed and passed.The id (internal diameter) test was performed and failed.Bubbles were surfacing approximately 5.5 mm from the distal tip, indicating a leakage too high failure during the continuity test.Fibers were inspected using the exfo scope and fibers appeared to be smooth with no signs of damage.The root cause of failed continuity test is attributed to a torn liner.
Event or Problem Description
Refer to h10/h11 for follow-up information.

• Brand Name: ION
• Common Device Name: CATHETER
• 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: 16368449
• Report Number: 2955842-2023-10656
• Device Sequence Number: 12648221
• Product Code: EOQ
• UDI-Device Identifier: 00886874116258
• UDI-Public: (01)00886874116258(10)S11221020
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K182188
• 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): 01/18/2023

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: 490105-31
• Device Catalogue Number: 490105
• Device Lot Number: S11221020 0012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/18/2023
• Supplement Date Received by Manufacturer: 02/14/2023
• Initial Report FDA Received Date: 02/13/2023
• Supplement Report FDA Received Date: 03/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/20/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• 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