ENDOSCOPE REPROCESSOR recallZ-2344-2023 · Olympus Corporation of the Americas · initiated May 26, 2023

Why it was recalled

Revised OER-Pro, OER-Elite, OER-Mini endoscope reprocessor labeling- the LF-V and LF-P are no longer compatible endoscopes for reprocessing in the OERs. The addendum highlights the following changes: 1. Removal of LF-V and LF-P as compatible with the OER 2. Change conditions for ETO gas sterilization from 12% EtO to 100% EtO 3. Removing the reusable cleaning brush for the manual cleaning. Single Use brushes remain compatible

FDA root cause category: Labeling Change Control

What the company is doing

Olympus issued two Urgent: Medical Device Corrective Action letters: (1) VISERA TRACHEAL INTUBATION VIDEOSCOPE OLYMPUS LF TYPE V (LF-V) TRACHEAL INTUBATION FIBERSCOPE OLYMPUS LF-P (LF-P) (2)ENDOSCOPE REPROCESSOR Affected Models: OER-ProTM, OER-MiniTM and OER-EliteTM. Letters states reason for recall, health risk and action to take: Our records indicate that your facility has purchased one or more LF-V and LF-P scopes. (1)Olympus requests you to take the following actions: 1. Ensure all personnel are completely knowledgeable and thoroughly trained on the changes to the reprocessing instructions described in this letter. 2. If you are using OER for high level disinfection of your LF-V and LF-P, please transition to another compatible method of reprocessing as soon as possible. 3. Locate and replace any on-hand copies of the LF-V and LF-P Instructions for Use with the updated version. Obtain a copy of the updated IFU by accessing our Olympus Connect website: How to access the Instructions for Use a) Log in to www.OlympusConnect.com b) Select Product Support , then Instruction Manuals c) Navigate to the document entitled LF-V Instruction Manual and LF-P Instruction Manual If you require additional information about the updated Instruction for use, or need assistance with accessing Olympus Connect, please contact our Technical Assistance Center (TAC) at 1-800-848-9024 (option 1). The TAC department can assist you in answering questions on the new Instructions Manual and new steps. 4. If a Scope ID tag (MAJ-1545) is used with your LF-V and LF-P, please dispose of your MAJ-1545 since the LF-V and LF-P cannot be used with OERs. 5. Complete the enclosed response form and return to our recall partner, Sedgwick, via Email ([email protected]) or Fax (866-842-0470). For any questions about the acknowledgement form, please call the Sedgwick team at 888-912-7350. (2)Our records indicate that your facility has purchased one or more of the afore mentioned endoscope

Recall details

Recall number

Z-2344-2023

Status

Open, Classified

Initiated by the company

May 26, 2023

Posted by the FDA

Aug 4, 2023

Recalling firm

Olympus Corporation of the Americas

Quantity

1063 units

Product code

FEB

FDA submissions

K201920

Distribution

Nationwide

Product description

Olympus Endoscope Reprocessor OER-Elite-For use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes and their accessories.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

• ENDOSCOPE REPROCESSOR OER-Elite

  Olympus Medical Systems Corp. · Accessories, cleaning, for endoscope
  4 recalls323 reports

Product lines

• ENDOSCOPE REPROCESSOROlympus Medical Systems Corp. · 3 models · 1,497 reports · 9 recalls

Other devices under the same FDA submission

3 devices cleared under K201920 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

• WATER FILTER MAJ-824

  Olympus Medical Systems Corp. · ACCESSORIES, CLEANING, FOR ENDOSCOPE
  7 reports
• AIR FILTER MAJ-823

  Olympus Medical Systems Corp. · ACCESSORIES, CLEANING, FOR ENDOSCOPE
  2 reports
• RETAINING RACK MAJ-840

  Olympus Medical Systems Corp. · ACCESSORIES, CLEANING, FOR ENDOSCOPE
  1 report

Other products in the same recall event

The FDA groups related products into one recall event (event 92633).

• Z-2340-2023 · Open, Classified
  VISERA Tracheal Intubation Videoscope OLYMPUS LF Type V- For airway management which includes endoscopic observation to access airway anatomy, endotracheal/endobronchial intubation…
• Z-2341-2023 · Open, Classified
  Tracheal Intubation Fiberscope OLYMPUS LF-P- To be used with an Olympus Light Source, documentation equipment, display monitor and other ancillary equipment for management of Endot…
• Z-2342-2023 · Open, Classified
  Olympus Endoscope Reprocessor OER-Pro-For use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes and their accessories.
• Z-2343-2023 · Open, Classified
  Olympus Endoscope Reprocessor OER-Mini-For use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes and their accessories.