URO GUIDE 6 FR X 26 CM
Received Sep 23, 2024
Report 3011050570-2024-00385 · MDR key 20279968
Device
Product problems
- Migration or Expulsion of Device
- Migration or Expulsion of Device
Patient
NA · Unknown
- Discomfort
- Discomfort
Narrative
Description of Event or Problem
IT WAS REPORTED THAT IMPLANTED STENT MIGRATED CAUSING PATIENT DISCOMFORT. THE PATIENT HAD ANOTHER PROCEDURE WHEREIN THE STENT WAS REMOVED AND A NEW (UNKNOWN MANUFACTURER) STENT WAS PLACED. ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER NO FURTHER INFORMATION HAS BEEN AVAILABLE AT THIS TIME. THE DEVICE WAS INSPECTED PRIOR TO USE.
Additional Manufacturer Narrative
THE DEVICE EVALUATION IS ONGOING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Additional Manufacturer Narrative
THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S (LM) INVESTIGATION. THE SUBJECT DEVICE WAS NOT RETURNED TO OLYMPUS FOR EVALUATION. HOWEVER, AN UNUSED DEVICE FROM THE SAME MODEL/LOT WAS RETURNED TO OLYMPUS BY THE FACILITY. THE DEVICE WAS RECEIVED IN ITS ORIGINAL PACKAGING, SEALED, AND WITH NO DAMAGE OR ABNORMALITIES OBSERVED. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. IT HAS BEEN OVER 1 YEAR SINCE THE SUBJECT DEVICE WAS MANUFACTURED. THE SUBJECT DEVICE WAS NOT RETURNED TO OLYMPUS FOR EVALUATION. BASED ON THE RESULTS OF THE INVESTIGATION, THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. THIS SUPPLEMENTAL REPORT INCLUDES INFORMATION ADDED TO H4. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.
Additional Manufacturer Narrative
CORRECTION TO PREVIOUSLY SUBMITTED INITIAL REPORT G3 WHICH SHOULD HAVE BEEN JULY 26TH, 2024 AND NOT SEPTEMBER 6TH, 2024. THE REPORT WAS SUBMITTED WITH SEPTEMBER 6TH, 2024 AS THE G3 DATE WHICH SIGNIFIES WHEN ADDITIONAL INFORMATION WAS RECEIVED ABOUT ANOTHER PROCEDURE NEEDING TO BE PERFORMED TO REPLACE THE STENT. THIS INFORMATION WAS TO ACCOMMODATE THE UPDATE IN B1 TO ADVERSE EVENT. HOWEVER, THE CUSTOMER REPORTED THE PRODUCT PROBLEM ON JULY 26TH, 2024 WHEN THEY ALLEGED THAT THE STENT MIGRATED. THEREFORE, THE G3 DATE OF THE INITIAL REPORT SHOULD HAVE BEEN JULY 26TH, 2024.