MalfunctionFCX
ENDOFLATOR 40
Received Jun 1, 2026
Report 9610617-2026-01245 · MDR key 25350313
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Product code (FCX)
Manufacturer (Karl Storz Se & Co. Kg)
Model (UI400)
Device
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."