EZDILATE BALLOON DILATOR (WG) 11-12-13
Received May 19, 2022 · Event occurred May 13, 2020
Report 3003790304-2022-00075 · MDR key 14434629
Device
Product problems
- Crack
- Crack
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
DURING AN ESOPHAGEAL DILATATION SURGERY, THE BALLOON WAS PUMPED TO 2 ATM ( MAX. 5.5. ATM) AND SUDDENLY CRACKED. NO PATIENT INJURY WAS REPORTED.
Additional Manufacturer Narrative
THE BALLOON WAS DISCARDED AND WILL NOT BE RETURNED FOR EVALUATION. THE INVESTIGATION IS ON-GOING. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY.
Additional Manufacturer Narrative
THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. IT HAS BEEN OVER 3 YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. BASED ON THE RESULTS OF THE INVESTIGATION, A DEFINITIVE ROOT CAUSE CANNOT BE IDENTIFIED. OLYMPUS WILL CONTINUE TO MONITOR THE FIELD PERFORMANCE OF THIS DEVICE.