AESCULAP AEOS
Received Apr 7, 2021 · Event occurred Mar 8, 2021
Report 9610612-2021-00276 · MDR key 11628140
Device
Product problems
- Material Integrity Problem
- Material Integrity Problem
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
BASED UPON INVESTIGATION RESULTS, THIS EVENT WAS RE-EVALUATED AND IS CONSIDERED NO LONGER REPORTABLE DUE TO RISK FILE. NO MALFUNCTION OR SERIOUS INJURY.
Additional Manufacturer Narrative
MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. SHOULD RELEVANT ADDITIONAL INFORMATION / INVESTIGATION RESULTS BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED TO AESCULAP INC. THAT A AESCULAP AEOS (PART # PV010) WAS BEING SETUP FOR PRODUCT DISPLAY. ACCORDING TO THE COMPLAINANT, THE AEOS UNIT WAS SETUP IN A HOTEL CONFERENCE CENTER TO DISPLAY TO LOCAL SURGEONS. REPORTEDLY, DURING SETUP TWO (2) HARDWARE ISSUES WERE OBSERVED: THE WHEEL OF THE SYSTEM WAS BROKEN; RIGHT HAND CONTROL WAS LOOSE. NO PATIENT INVOLVEMENT. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION HAS NOT BEEN MADE AVAILABLE. THE MALFUNCTION IS FILED UNDER AAG REFERENCE XC (B)(4). ASSOCIATED MEDWATCH-REPORTS: 9610612-2021-00275 ((B)(4)).