EASYSTE2020 ROUTER&CNTRL SYS
Received Feb 6, 2025 · Event occurred Jan 2, 2025
Report 3011050570-2025-00105 · MDR key 21323608
Device
Product problems
- Display or Visual Feedback Problem
- Display or Visual Feedback Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE EVENT WAS CONSERVATIVELY CLASSIFIED AS A SERIOUS INJURY DUE TO THE PROCEDURE ALLEGEDLY BEING PROLONGED BY 30 OR MORE MINUTES. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Description of Event or Problem
WHILE UNDER SEDATION FOR AN UNKNOWN THERAPEUTIC PROCEDURE, THE SUBJECT DEVICE WAS UNABLE TO CAPTURE IN THE FIELD. THIS LED TO A SURGICAL PROLONGATION GREATER THAN 30 MINUTES. THE PROCEDURE WAS COMPLETED USING A BACKUP DEVICE AND THERE WERE NO REPORTS OF PATIENT HARM.
Additional Manufacturer Narrative
THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE A CORRECTION TO THE PREVIOUSLY REPORTED CUSTOMER ALLEGATION. CORRECTED FIELD: B5. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Description of Event or Problem
WHILE UNDER SEDATION FOR AN UNKNOWN THERAPEUTIC PROCEDURE, THE SUBJECT DEVICE WAS NOT WORKING AT ALL.
Additional Manufacturer Narrative
THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE LEGAL MANUFACTURER¿S INVESTIGATION. UPDATED FIELDS: H2 AND H6. CORRECTIONS TO B1, B2, AND H1. THIS EVENT WAS INITIALLY CONSERVATIVELY REPORTED AS A SERIOUS INJURY; HOWEVER, THERE IS NO EVIDENCE THE PATIENT SUFFERED ANY SERIOUS INJURY OR ADVERSE EFFECTS FROM THE PROLONGED PROCEDURE. OLYMPUS MADE MULTIPLE ATTEMPTS TO RECEIVE MORE INFORMATION FROM THE CUSTOMER WITHOUT SUCCESS. THUS, CORRECTING B1, B2, AND H1. B1 SHOULD NOT BE MARKED AS AN ADVERSE EVENT, AND B2 SHOULD NOT BE MARKED AT ALL. H1 SHOULD ALSO NOT BE MARKED. THE H6 MEDICAL DEVICE PROBLEM REPORTED, AND OTHER FINDINGS WOULD NOT CAUSE OR CONTRIBUTE TO A DEATH OR A SERIOUS INJURY IF IT WERE TO RECUR. THE DEVICE WAS NO RETURNED TO OLYMPUS FOR EVALUATION AND THE COMPLAINT WAS NOT CONFIRMED. THE MOST PROBABLE CAUSE OF THE COMPLAINT IS (B)(4) WHICH IS THE INVESTIGATION FINDINGS DO NOT CLEARLY CONFIRM THE PRESENCE OR ABSENCE OF THE REPORTED PROBLEM WITH THE DEVICE. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.
Description of Event or Problem
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.