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

Model Number	490206-02
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during central processing, the peripheral vision probe failed the leak test.The user completed the diagnostic procedure using the same system.No fragment fell into the patient.No known impact or patient consequence was reported.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
The peripheral vision probe has been returned and evaluated by the failure analysis team.The air leak test was conducted and failed.A steady stream of bubbles was coming at the distal end of the probe tip, indicating a damaged vision probe.Additional observation not reported was physical damage at the distal tip.Adhesive joint is no longer present at one of the slots of the distal tip that secures the illumination fiber, allowing air bubbles to come out during the air leak test.This vision probe was transferred to the engineering team to confirm the adhesive/potting joint was manufacturing related and not used induced.The rma was reviewed with ion vision probe manufacturing engineer.One of the two illumination fibers was observed to be recessed from the distal tip.Upon cutting opening the vision probe shaft and viewing the fiber, adhesive was observed to be present on the distal tip of the fiber.The recessed 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.There is a potential for fragments of adhesive or fiber due to this failure mode as the adhesive bond failed at the distal tip which enter the patient.

• 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: 19621481
• Report Number: 2955842-2024-16379
• Device Sequence Number: 8121926
• Product Code: EOQ
• UDI-Device Identifier: 00886874121184
• UDI-Public: (01)00886874121184(11)240222(10)S12240222
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): 06/04/2024

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: S12240222 0044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/04/2024
• Initial Report FDA Received Date: 06/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/22/2024
• 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: Prefer Not To Disclose