MalfunctionFCX
ENDOFLATOR 40
Received May 21, 2026 · Event occurred Apr 29, 2026
Report 9610617-2026-01148 · MDR key 25246908
Device
Product problems
- Output Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE AFFECTED DEVICE HAS BEEN REQUESTED FOR INVESTIGATION BY THE MANUFACTURER. DEVICE WAS NOT RETURNED AT THE TIME OF MDR SUBMISSION. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).
Description of Event or Problem
THE FOLLOWING WAS REPORTED: DURING THE LAPAROSCOPIC PROCEDURE, THE INSUFFLATOR SUDDENLY STOPPED INSUFFLATING, PREVENTING THE SURGERY FROM PROCEEDING NORMALLY. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.