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EVIS EXERA II COLONOVIDEOSCOPE recallZ-1132-2023 · Olympus Corporation of the Americas · initiated Dec 21, 2022

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Olympus Corporation of the Americas or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

A single CF-Q180AL colonovideoscope was utilized in a veterinary endoscopy procedure in advance of being assigned to a medical facility as a service loaner in error, potential for microbial contamination

FDA root cause category: Process design

What the company is doing

Olympus issued Urgent Field Safety Notice communication for the customers without the device on December 21, 2022 via FedEx 2-day delivery.. Letter states reason for recall, health risk and requires the following action: Although the device is no longer in your possession, Olympus requires you to take the following action: 1. Evaluate the situation according to your hospital procedures to determine if additional actions, including patient notification and/or clinical follow up, may be required. 2. Review affected patient records and report any potentially related adverse events (such as infection) to Olympus and FDA (instructions below). 3. Olympus requests that you acknowledge receipt of this letter by accessing the Olympus recall portal. Go to https://olympusamerica.com/recall. Enter reference number 0419 and provide your contact information as indicated in the portal. Olympus requests that you report any complaints, including infections, to Olympus and the FDA. Please report complaints to our Technical Assistance Center (TAC) at 1-800-848-9024, option 1. Contact (647) 999-3203 or at [email protected] for any additional information or support concerning this matter. ***Update*** Firm provided recall delivered Urgent Medical Device Recall to one consignee dated 1/19/23 on 1/20/23 to customer. Letter states: Inspect your inventory for this model and serial number. Your local Sales Representative will assist in the return of the unit to Olympus and arrange either an exchange for a Certified Pre-Owned scope or a credit at fair market value. 2. Evaluate the situation according to your hospital procedures to determine if additional actions, including patient notification and/or clinical follow up, may be required. 3. Review affected patient records and report any potentially related adverse events (such as infection) to Olympus and FDA (instructions below). 4. Acknowledge receipt of this letter by e-mail response to your Sales Representative or to me directly a

Recall details

Recall number
Z-1132-2023
Status
Open, Classified
Initiated by the company
Dec 21, 2022
Posted by the FDA
Feb 13, 2023
Recalling firm
Olympus Corporation of the Americas
Quantity
1 unit
Product code
NWB
FDA submissions
K100584
Distribution
US Nationwide distribution in the states of CA, FL, GA, NY, OR, VA.

Product description

EVIS EXERA III Colonovideoscope-For endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum, sigmoid colon, colon, and ileocecal valve) Model/Serial: CF-Q180AL

Code information (models, lots, serial numbers)

UDI: 04953170202315 Serial number 2807443

Devices named in this recall

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

Product lines

Sources and updates

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