Recall Z-3311-2018 ยท EOQ Bronchoscope (Flexible Or Rigid)
Olympus Corporation of the Americas
Airway Mobilescope MAF-TM
| Date | Aug 8, 2018 |
| Status | Terminated |
| Reason | The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have resulted in more applied force than expected and lead to loosening of the instrument channel port. |
| Root cause | Other |
| Action | Urgent Medical Device Safety Notice letters dated 8/8/18 were distributed to customers. The letters instructed customers to perform the following: Our records indicate that your facility has purchased one or more of the above-referenced endoscopes. OLYMPUS requires that you take the following actions: Inspect your inventory for the referenced Olympus models. Please keep this customer letter in your inventory and conduct the following action prior to every use. Step 1: Wearing sterile gloves, attempt to rotate or turn the instrument channel port in counter-clock direction as shown in pict |
| Quantity | 3456 |
| Distribution | The products were distributed US nationwide and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K082720 | TRACHEAL INTUBATION FIBERVIDEOSCOPE, MODELS LF-Y0004 AND LF-Y0005 Olympus Medical Systems Corporation, Nov 5, 2008 |