MalfunctionFCX
ENDOFLATOR 40
Received Jul 9, 2026
Report 9610617-2026-01583 · MDR key 25766532
Device
Product problems
- Gas Output Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE DEVICE IN QUESTION WAS RETURNED TO MANUFACTURER AS REFLECTED IN SECTION D9. THE INVESTIGATION IS NOT YET COMPLETE, INVESTIGATION RESULTS ARE PENDING. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).
Description of Event or Problem
IT WAS REPORTED THAT A MALFUNCTIONING PRESSURE SENSOR CAUSING THE PRESSURE TO EXCEED THE SETPOINT, WHICH MAY TRIGGER THE OVERPRESSURE ALARM RANDOMLY. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.