Home Medizin Olympus erlässt Rückrufkorrektur für Bronchoskope

Olympus erlässt Rückrufkorrektur für Bronchoskope

von NFI Redaktion

According to a statement from the U.S. Food and Drug Administration (FDA), a number of bronchofiberscopes and bronchovideoscopes by Olympus were recalled by the manufacturer due to the risk of burns and fires.

However, the FDA clarified that this recall is a correction, not a product removal. Physicians are not required to discontinue the use of these devices, but they must be aware of the risks and take the precautions outlined by Olympus.

„While healthcare providers may choose to continue using Olympus bronchofiberscopes and bronchovideoscopes to maximize patient safety and mitigate potential health risks, the FDA and Olympus recommend that users refrain from performing high-frequency cautery during oxygen insufflation and carefully follow these instructions,“ said an FDA spokesperson.

The recall affects bronchofiberscopes and bronchovideoscopes by Olympus that were distributed between January 1, 2001, and September 11, 2023. According to the FDA, the use of these devices can lead to serious adverse events in patients and physicians, including severe burns to the airways or lungs, airway bleeding, breathing difficulties, respiratory arrest, unconsciousness, or death in patients undergoing treatment using these devices. Medical personnel using the devices can also be affected by burns.

Olympus sent out a letter of urgent corrective action for medical devices on October 12, 2023. The letter described the risks associated with the devices, stating, „There is a risk of endobronchial burns when high-frequency cautery is performed under oxygen insufflation,“ and „The electrode portion of the electro-surgical accessory is located too close to the distal end of the endoscope.“

To mitigate this risk, Olympus reminded physicians to adhere to the warnings in the device’s instructions, especially these three:

  • Avoid performing high-frequency cautery under oxygen insufflation
  • Ensure that the electrode portion of the electro-surgical equipment used with the endoscope is at a safe distance from the distal end of the endoscope
  • Use the Olympus bronchoscopes only with compatible high-frequency therapy devices, as described in the instructions

The letter also urged facilities that purchased the affected bronchoscopes to ensure that all personnel are „fully informed and instructed“ regarding the warnings in the instructions. It stated that users are still allowed to continue using the devices in accordance with the current instructions and warnings.

Olympus Statement

„Olympus Corporation initiated this field corrective action to address complaints of endobronchial burns occurring when high-frequency compatible bronchoscopes are used in therapeutic procedures combined with high-frequency therapy devices,“ said an Olympus spokesperson. „This corrective action was taken following a comprehensive assessment of complaints related to severe patient injuries. Olympus takes these complaints very seriously, and patient safety is our top priority.“

„The customer notification is intended to remind users of existing warnings not to use oxygen during high-frequency cautery and to maintain a proper distance when using high-frequency therapy devices,“ she said. „The products are not being removed currently and there are no changes being made to the labeling.“

For clinicians, the spokesperson stated, „Users can continue to use Olympus bronchoscopes in accordance with the instructions in the operation manual and the customer letter. This is not a removal action. There are no changes to the existing operation manual regarding the compatibility of bronchoscopes with high-frequency therapy devices.“

„As for future actions, in addition to the communication included in this corrective action, which will remind users about recommendations for using oxygen and maintaining appropriate distance when using high-frequency therapy devices, the root cause and potential contributing factors are currently being investigated as part of a formal CAPA (Corrective Action Preventative Action) process. Olympus will take all appropriate corrective actions based on the investigation results,“ the Olympus spokesperson added.

In 2016, Olympus made headlines in the medical field when it recalled its TJF-Q180V duodenoscope following congressional investigations after the product was linked to bacterial infection spread due to design flaws.

Customers in the U.S. with questions about the recall can contact Olympus at 1-800-848-9024 (Option 1). Healthcare professionals and consumers can report adverse events or quality problems related to the devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program via an online form, mail, or fax.

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