inforMED
MalfunctionFBO

INNER TUBE FOR 27040 SD/SL

Received Oct 15, 2025 · Event occurred Sep 25, 2025

Report 9610617-2025-01785 · MDR key 23281755

Device

Generic name

Inner Tube For 27040 Sd/sl

Model number

27040XAL

Catalog number

27040XAL

Lot number

OK01

Product problems

  • Display or Visual Feedback Problem
  • Display or Visual Feedback Problem

Patient

NA · Male

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

THE DEVICE WAS RETURNED TO OUR US FACILITY, AND WILL LATER BE FORWARDED TO THE MANUFACTURING SITE FOR INVESTIGATION. SHOULD RELEVANT ADDITIONAL INFORMATION / INVESTIGATION RESULTS BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UNSOLICITED. THIS EVENT IS FILED UNDER INTERNAL COMPLAINT ID (B)(4). CROSS REFERENCE COMPLAINT ID (ON THE 27068CD BRIDGE AS A COCONMITANT ITEM): (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT "COMBINATION OF 27040XAL AND 27068CD BRIDGE CAUSED POOR IMAGE ON SCREEN". IT WAS CONFIRMED THAT THERE WAS NO PATIENT INJURY OR IMPACT DUE TO THE REPORTED ISSUE AND THE SURGEON WAS ABLE TO COMPLETE THE PROCEDURE WITHOUT DELAY. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. CROSS REFERENCE COMPLAINT ID (ON THE 27068CD BRIDGE AS A COCONMITANT ITEM): (B)(4).