AUTOMATED ENDOSCOPE LEAK TESTER

Additional Manufacturer Narrative

THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE LEGAL MANUFACTURER¿S INVESTIGATION AND THE RESULTS OF THE DEVICE HISTORY RECORDS (DHR) REVIEW. NEW INFORMATION WAS ADDED TO THE FOLLOWING FIELDS: THE DHR FOR THIS DEVICE WERE REVIEWED AND ALL RECORDS INDICATED THE PRODUCT WAS MANUFACTURED ACCORDING TO ALL APPLICABLE PROCEDURES AND MET FINAL PRODUCT RELEASE CRITERIA. NO ABNORMALITIES WERE FOUND. A DEFINITIVE ROOT CAUSE WAS NOT IDENTIFIED. BASED ON THE AVAILABLE INFORMATION, THE LEGAL MANUFACTURER DETERMINED THE PROBABLE CAUSE OF THE FAILURE IS UNABLE TO BE DETERMINED.

Additional Manufacturer Narrative

THE SUSPECT DEVICE HAS NOT BEEN RETURNED TO OLYMPUS FOR EVALUATION AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH DEVICE EVALUATION RESULTS. THIS EVENT HAS BEEN SUBMITTED BY THE IMPORTER ON MDR# 2951238-2021-00423.

Description of Event or Problem

THE CUSTOMER REPORTED TO THE OLYMPUS EMPLOYEE THERE IS A PATIENT INFECTION FOLLOWING THE USE OF AN UNKNOWN SCOPE. THE CUSTOMER STATES THE AUTOMATED ENDOSCOPE LEAK TESTER DID NOT DETECT A LEAK ON THE SCOPE USED WITH THE PATIENT. A REQUEST FOR ADDITIONAL INFORMATION IS IN PROGRESS.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION WAS RECEIVED FROM AN OLYMPUS REPRESENTATIVE: THE INDIVIDUAL WENT INTO FACILITY TO INVESTIGATE LEAK TESTING PRACTICES. CUSTOMER IS FOLLOWING ALL LEAK TESTING GUIDELINES AND ARE PERFORMING LEAK TESTING APPROPRIATELY. THIS FALSE READING FROM THE ALT-PRO LEAK TESTER CAME FROM FAULTY LEAK TEST CONNECTORS WHICH SINCE HAVE BEEN REPLACED. NEW LEAK TESTER CONNECTORS WERE TESTED AND PUT INTO CIRCULATION. AFTER FOLLOWING UP WITH CUSTOMER, THERE HAS NOT BEEN A PROBLEM SINCE. THEREFORE, THE LEAKAGE LIKELY OCCURRED DUE TO FAILURE OF THE LEAK TEST CONNECTOR; HOWEVER, INFORMATION ON INFECTION COULD NOT BE OBTAINED.