MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ION; VISION PROBE

Model Number	490206-02
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an ion endobronchial lung biopsy procedure, the 1.5 peripheral vision probe broke.The diagnostic procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter on and obtained the following additional information: no fragments fell into the patient.The patient has not returned to the hospital due to experiencing any post-surgical complications related to retention of foreign material.The patient demographic information was provided.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) has received the 1.5 peripheral vision probe instrument associated with the customer-reported complaint.The instrument was analyzed, and it was discovered that the vision probe had both illumination fibers dislodged and protruding from the distal tip.However, no damage to the pins at the connector body was observed during the inspection.The cable adapter was also inspected, and no moisture or fluid was found.The vision probe was then installed on an in-house system and passed initialization.The led light at the distal tip was illuminating, and a video image was displayed on the monitor.There were additional observations not reported by the site: an air leak test was conducted and failed.A singular bubble was observed surfacing from the distal tip every 10-15 seconds.During visual inspection, it was found that the instrument had white residue on the magnet of the connector body.This residue could not be removed during in-house testing.The product was transferred to engineering for further investigation.During the investigation, it was observed that one of the two illumination fibers was protruding from the distal tip.There was adhesive present on the distal tip of the fiber.The protruding fiber is likely due to a failure of the adhesive bond that secures the fiber in the tip of the probe.The failure is most likely due to inadequate primer or adhesive application during manufacturing.

• Brand Name: ION
• Common Device Name: VISION PROBE
• 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: 20035392
• Report Number: 2955842-2024-18513
• Device Sequence Number: 16912986
• Product Code: EOQ
• UDI-Device Identifier: 00886874121184
• UDI-Public: (01)00886874121184(11)231214(10)S11231214
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K212048
• 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): 07/31/2024

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: 490206-02
• Device Catalogue Number: 490206
• Device Lot Number: S11231214 0082
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/31/2024
• Initial Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/14/2023
• 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 Age: 53 YR
• Patient Sex: Male
• Patient Weight: 95 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White