inforMED
MalfunctionFCX

ENDOFLATOR 40

Received Jul 2, 2026 · Event occurred Jun 18, 2026

Report 9610617-2026-01501 · MDR key 25696383

Device

Generic name

Endoflator 40

Model number

UI400

Catalog number

UI400

Product problems

  • Output Problem

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

THE AFFECTED DEVICE HAS BEEN REQUESTED BY THE MANUFACTURER. THE DEVICE HAS NOT YET RETURNED FOR INVESTIGATION. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT AN ALARM APPEARED DURING USE ON THE DEVICE. THE CLINICAL PERSONAL WAS UNABLE TO REPRODUCE THIS ERROR. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.