LITHOSTENT 7.0X28CM
Received Jan 1, 2024 · Event occurred Dec 11, 2023
Report 3011050570-2024-00003 · MDR key 18423320
Device
Product problems
- Packaging Problem
- Packaging Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
CORRECTION: E2 AND E3 WERE INADVERTENTLY OMITTED FROM THE INITIAL REPORT. 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. BASED ON THE RESULTS OF THE INVESTIGATION, THE ROOT CAUSE OF THE EVENT WAS UNABLE TO BE IDENTIFIED. THE REPORTED COMPLAINT WAS CONFIRMED. THE PACKAGE BEING CRUSHED LIKELY HAPPENED DURING TRANSPORT. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.
Additional Manufacturer Narrative
THE DEVICE WAS NOT RETURNED TO OLYMPUS FOR EVALUATION. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR IF ANY ADDITIONAL INFORMATION IS PROVIDED BY THE USER FACILITY.
Description of Event or Problem
THE CUSTOMER REPORTED TO OLYMPUS, THE LITHOSTENT HAD A CRUSHED PACKAGE ON TRANSPORT. THE STERILITY WAS COMPROMISED. THE ISSUE WAS FOUND DURING RECEIPT INSPECTION. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT.