OES CHOLEDOCHO FIBERSCOPE
Received Nov 7, 2023 · Event occurred Aug 2, 2023
Report 9610595-2023-16642 · MDR key 18088071
Device
Product problems
- Detachment of Device or Device Component
- Detachment of Device or Device Component
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. BASED ON THE RESULTS OF THE INVESTIGATION, THE DEVICE WAS NOT RETURNED TO OLYMPUS AND THE EVENT, ¿DISTAL END OF THE DEVICE CAME OFF¿, WAS NOT CONFIRMED. THE ROOT CAUSE COULD NOT BE IDENTIFIED. HOWEVER, THE SUBJECT DEVICE WAS REPAIRED BY THIRD PARTY AGENCY, AND IT WAS PROBABLE THAT REPAIR AGAINST INSTRUCTIONS FOR USE (IFU) WAS PERFORMED. IFU PROHIBITS REPAIR BY THIRD PARTY AGENCY OTHER THAN OLYMPUS. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. IT HAS BEEN OVER 13 YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. THE INSTRUCTION MANUAL IDENTIFIES THE FOLLOWING RELATED VERBIAGE WHICH COULD HAVE PREVENTED THE PHENOMENON: ¿INSTRUCTION_ IMPORTANT INFORMATION ¿ PLEASE READ BEFORE USE_ PROHIBITION OF IMPROPER REPAIR AND MODIFICATION: THIS INSTRUMENT DOES NOT CONTAIN ANY USER-SERVICEABLE PARTS. DO NOT DISASSEMBLE, MODIFY, OR ATTEMPT TO REPAIR IT; PATIENT OR OPERATOR INJURY AND/OR EQUIPMENT DAMAGE CAN RESULT. EQUIPMENT THAT HAS BEEN DISASSEMBLED, REPAIRED, ALTERED, CHANGED, OR MODIFIED BY PERSONS OTHER THAN OLYMPUS¿ OWN AUTHORIZED SERVICE PERSONNEL IS EXCLUDED FROM OLYMPUS¿ LIMITED WARRANTY AND IS NOT WARRANTED BY OLYMPUS IN ANY MANNER.¿ OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.
Additional Manufacturer Narrative
THE DEVICE WAS NOT RETURNED TO OLYMPUS FOR EVALUATION AND FOLLOW UP WITH THE USER FACILITY IS CURRENTLY BEING PERFORMED. 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 OES CHOLEDOCHO FIBERSCOPE DISTAL END COMPONENT FELL DUE TO THIRD PARTY REPAIR. THE ISSUE WAS FOUND DURING INSPECTION AFTER THE PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.