IGLESIAS WORKING ELEMENT
Received Aug 10, 2020
Report 3003790304-2020-00066 · MDR key 10389040
Device
Product problems
- Physical Resistance/Sticking
- Physical Resistance/Sticking
Patient
Not reported
- No Patient Involvement
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
UPON REVIEW, IT WAS DETERMINED THAT THIS INCIDENT HAS PREVIOUSLY BEEN REPORTED ON REPORT #1519132-2020-00021. THIS REPORT HAS BEEN DETERMINED TO BE A DUPLICATE.
Additional Manufacturer Narrative
THE DEVICE WAS RETURNED TO OLYMPUS AND EVALUATED. THE REPORTED PROBLEM COULD NOT BE DUPLICATED AND A ROOT CAUSE COULD NOT BE DETERMINED; HOWEVER, IT WAS DETERMINED THE DEVICE FAILED THE LEAKAGE TEST DUE TO A LEAK FROM THE LOCK BODY AND TUBE ASSEMBLY. NOTE: THIS MDR IS BEING SUBMITTED RETROSPECTIVELY AS PART OF A REMEDIATION EFFORT RELATED TO RECENT SYSTEM AND PROCESS CHANGES. A CAPA HAS BEEN OPENED TO MANAGE THE ACTIONS RELATED TO REMEDIATION OF THIS ISSUE AND ANY REQUIRED MDR REPORTING.
Description of Event or Problem
A USER FACILITY REPORTED TO OLYMPUS THAT THE ELECTRODE WAS STUCK IN WORKING ELEMENT AND COULD NOT BE REMOVED. THERE WAS NO PATIENT INJURY OR HARM, ASSOCIATED WITH THE PROBLEM, REPORTED TO OLYMPUS. THE PROBLEM, AS REPORTED, WAS FOUND DURING REPROCESSING.
Additional Manufacturer Narrative
THIS SUPPLEMENTAL REPORT IS SUBMITTED TO CORRECT THE MANUFACTURER FACILITY NUMBER AND PROVIDE THE RESULTS OF A DEVICE HISTORY RECORD (DHR) REVIEW. MANUFACTURER FACILITY NUMBER: (B)(4). THE DHR FOR THE PRODUCT INVOLVED WAS REVIEWED. NO ANOMALIES WERE NOTED AND IT WAS VERIFIED THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATIONS AND PROCEDURES.