inforMED
MalfunctionFCX

ENDOFLATOR 40

Received Jun 1, 2026

Report 9610617-2026-01245 · MDR key 25350313

Add to watch list
Product code (FCX)
Manufacturer (Karl Storz Se & Co. Kg)
Model (UI400)

Device

Generic name

Endoflator 40

Model number

UI400

Catalog number

UI400

Product problems

  • Insufficient Device Problem Information

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

THE DEVICE IN QUESTION WAS RETURNED TO THE MANUFACTURER. THE EVALUATION IS ANTICIPATED BUT NOT YET BEGUN. THE INVESTIGATION WILL BE PERFORMED BY A DESIGNATED KARL STORZ EMPLOYEE. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT "3FD: POWER ON TEST ERROR" IS DISPLAYED AFTER THE DEVICE IS CONNECTING THE GAS."