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Date: XX.XX.XXXX Olympus reference: QIL FY24-EMEA-02-FY23-OMTA-39
URGENT FIELD SAFETY NOTICE Reprocessing Manual Update for 4K CAMERA HEAD OLYMPUS CH-S400-XZ-EB Material ID N5401750
Model Name CH-S400-XZ-EB
Product Name 4K CAMERA HEAD
Serial Number all serial numbers after 7030001 and before 7231311
Dear Customer, Olympus is writing to inform you of a revised, corrected repossessing manual for 4K CAMERA HEAD OLYMPUS CH-S400-XZ-EB. The camera head has been designed to be used with Olympus endoscopes, camera control unit, and other ancillary equipment for endoscopic diagnosis, treatment, and observation. Background 4K CAMERA HEAD OLYMPUS CH-S400-XZ-EB is not autoclave-compatible but the table in the reprocessing manual incorrectly shows it is autoclave-compatible. Corrected reprocessing instruction for the CH-S400-XZ-EB Olympus is providing in this letter an Addendum that corrects the List of compatible methods in the reprocessing manuals. Please review the enclosed Addendum for detail. Risk to Health Autoclaving can severely damage the device potentially resulting in image loss prior to or during a procedure. This may result in a delay, prolongation or cancellation of a procedure. Image loss while performing critical portions of a procedure could result in tissue/organ injury, hemorrhage, and an additional intervention/surgery. Action steps to be taken by the end user: Our records indicate that your facility has purchased one or more of the affected CH-S400-XZ-EB. Olympus requires you to take the following actions: 1. Inspect your inventory for the referenced devices and identify any device with the CH-S400-XZ-EB model name. Please check all areas of the hospital to determine if any of these devices remain in inventory. The model number and serial number can be found on the device as illustrated in the following picture.
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model number
serial number
2. Carefully read the content of this Field Safety Notice as well as the attached “Addendum”. List of compatible methods was corrected. (Correct: Not compatible, Incorrect: Compatible). 3. Ensure all personnel is completely knowledgeable on this labeling change. 4. If your facility requires the latest version of the CH-S400-XZ-EB reprocessing manual, please indicate this in the reply form. Alternatively, the new version of the CH-S400-XZ-EB reprocessing manual can be found on the Olympus webpage www.olympus-europa.com under Medical Systems Products & Solutions Instruction Manual Search for “CH-S400-XZ-EB” model name. 5. Send the completed Reply Form back to your local Olympus representative at [XXXXXXX] latest by [XX.XX.XXXX]. 6. If you have distributed these devices outside your facility, please notify your customers of this matter immediately by forwarding them this Field Safety Notice. Please appropriately document your notification process and let us know the end-customer feedback accordingly. Olympus regrets any inconveniences caused by this Field Safety Notice and fully appreciates your prompt cooperation in addressing this situation. In case of any questions or concerns, please do not hesitate to contact Olympus directly at [phone number] or at [e-mail address]. Sincerely, Name Title, Department/Region
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Addendum to the Reprocessing Manual of the CH-S400-XZ-EB Revised "List of compatible methods" in the Section 3.2 Before revised (RA6335 ver.03 -P.12)
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After revised (RA6335 ver.04 -P.12)
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REPLY FORM – QIL FY24-EMEA-02-FY23-OMTA-39 URGENT FIELD SAFETY NOTICE Model name: CH-S400-XZ-EB [Name & Address of Hospital/Medical Facility]
[Dept/Attn]
[Inventory information (Serial Number(s) of CH-S400-XZ-EB)] Model
Serial Number
[Quantity of CH-S400-XZ-EB Reprocessing Manual hard copies or electronic pdf documents required] [Date] Dear Sirs or Madams, I herewith confirm the receipt of your Field Safety Notice. Further I confirm that I have transferred the content of the attached FSN to all affected departments on which this action has an impact. I understand the necessity to follow the steps. Name (Signature)
___________________________________
Name (Print)
___________________________________
Position
___________________________________
Please scan / email your completed paper form response to [XXXXXXX
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