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

Model Number	490105-11
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	09/29/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the catheter instrument involved with this complaint and completed the device evaluation.Failure analysis investigation replicated/confirmed the customer reported complaint.Failure analysis found the primary failure of lodged component to be related to the customer reported complaint.The catheter was found to have a lodged metal piece at the distal tip opening.Visual inspection was performed and found no damage to the sensor connector and tool channel.The catheter was shaken, and no signs of water intrusion observed.Fibers were inspected using the exfo scope and fibers appeared to be smooth and no signs of damage.No available logs for review.The catheter was transferred to engineering for further investigation.The catheter was reviewed by an isi advanced failure engineering team.An obstruction was observed at the distal tip of the device.The object was unable to be pushed out of the distal tip using a zibrascope and was unable to be pulled out of the distal tip using tweezers.The object was observed to be non-rigid and would bend when pressed on.A cylindrical metal rod was used to push the object proximally inside the catheter shaft.The object was pushed out of the proximal end of the tool channel using the metal rod.The object was measured to be approximately 5.23 mm in length and appeared to have 4 flat sides with rounded edges, with 1 of the 4 sides folded in on itself.Object appeared to be part number 962335-03 (aid,extrusion,proximal,peek,black) left in the device from manufacturing.The root cause of peek key lodged in the distal tip is attributed to manufacturing.This complaint is reportable malfunction event due to the following conclusion: failure analysis acknowledges that a fragment was missing from a portion of the device that enters the patient (distal end).Based on the information provided, there was no report from the customer that a fragment from the instrument fell into the patient during the procedure.While there was no report of harm or injury to the patient, the reported failure mode could likely cause or contribute to an adverse event if it were to recur.
Event or Problem Description
It was reported that prior to the start of an ion endobronchial lung biopsy procedure, the catheter instrument distal tip had a metal blocking.The diagnostic procedure was completed with no reported injury.

• 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: 16440892
• Report Number: 2955842-2023-10903
• Device Sequence Number: 14240492
• Product Code: EOQ
• UDI-Device Identifier: 00886874116258
• UDI-Public: (01)00886874116258(10)S11220604
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 01/31/2023

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: 490105-11
• Device Catalogue Number: 490105
• Device Lot Number: S11220604 0030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/31/2023
• Initial Report FDA Received Date: 02/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/04/2022
• 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: Reuse
• 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: ION ENDOLUMINAL SYSTEM.
• Patient Sex: Unknown