Recall Z-0138-2017 ยท FEB Accessories, Cleaning, For Endoscope
Olympus Corporation of the Americas
OER-Pro Endoscope Reprocessor, Endoscope washer/disinfector
| Date | Oct 19, 2016 (initiated Jun 23, 2016) |
| Status | Terminated |
| Reason | New warning requiring Users to conduct duodenoscope precleaning and manual cleaning even when using an Automated Endoscope Reprocessor (AER) that has instructions that may indicate a user could forego certain steps in precleaning and manual cleaning of the endoscopes. |
| Root cause | Under Investigation by firm |
| Action | Olympus America Inc. (OAI) mailed a letter to customers informing them that they are issuing an updated Operation Manual for the OER-Pro Automated Endoscope Reprocessor. The following actions were asked to be taken: -Olympus has discontinued previously distributed copies of the OER-Pro Operation Manual. - Inspect your inventory of Operation Manuals and discard any existing inventory of OER-Pro Operation Manuals. - Implement use of the enclosed OER-Pro Operation Manual, which contains the new Warning on pages 73 and 80. - Ensure all reprocessing personnel are completely knowledgeable and |
| Quantity | 2, 686 units |
| Distribution | Distributed to: AK,AL,AR,AZ,CA,CO,CT,DC,DE,FL,GA,HI,IA,ID,IL,IN,KS,KY,LA,MA,MD,ME,MI,MN,MO,MS,MT,NC,ND,NE,NH,NJ,NM,NV,NY,OH,OK,OR,PA,RI,SC,TN,TX,UT,VA,VT,WA,WI,WV,WY |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K103264 | ENDOSCOPE REPROCESSOR OER-PRO MODEL OER-PRO Olympus Medical Systems Corporation, Feb 23, 2011 |