IGLESIAS WORKING ELEMENT
Received Jun 18, 2020
Report 1519132-2020-00021 · MDR key 10171843
Device
Product problems
- Device Damaged by Another Device
- Device Damaged by Another Device
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. THE INVESTIGATION CODING WAS ADDED.
Additional Manufacturer Narrative
THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. THE DHR REVIEW OF THE EIWE SERIAL/LOT NUMBER GO WAS SHIPPED AS AN REX SCOPE, MANUFACTURED JULY 2010, DID NOT FIND ANY DEFECTS, NONCONFORMING ISSUE OR ANY CORRECTIVE ACTION ISSUES DURING THE ASSEMBLY BUILD OF THE DEVICE. ALL RECORDS INDICATE THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH ALL APPLICABLE PROCEDURES AND FINAL PRODUCT RELEASE CRITERIA.
Additional Manufacturer Narrative
THE DEVICE WAS RETURNED TO THE SERVICE CENTER FOR EVALUATION. THE WORKING ELEMENT FAILED LEAKAGE TEST DUE TO LEAK FROM LOCK BODY AND TUBE ASSEMBLY. THE INSTRUCTION MANUAL STATES SECTION ¿CAUTIONS INDICATE THAT EQUIPMENT MAY BE DAMAGED OR MAY MALFUNCTION BY MISUSE.¿
Description of Event or Problem
THE SERVICE CENTER WAS INFORMED THAT DURING REPROCESSING THE ELECTRODE WAS NOTED TO BE STUCK IN THE WORKING ELEMENT. THERE WAS NO PATIENT INJURY REPORTED.