Olympus Initiates Recall for Select ViziShot 2 FLEX Needles
Olympus Implements Voluntary Recall of ViziShot 2 FLEX Needles
Recently, Olympus Corporation took a significant step by announcing a voluntary recall for specific lots of its ViziShot 2 FLEX (19G) EBUS-TBNA needles. This action was prompted by reported incidents where components detached during medical procedures, raising alarms about patient safety.
Details of the ViziShot 2 FLEX Needle
The ViziShot 2 FLEX needle, designed with a hypotube and sheath, ensures stability and protection during medical interventions. However, if the sheath sustains any damage, critical components may detach, leading to serious complications. Olympus reported that defects may also have originated during the manufacturing process. To enhance quality control, the company has now implemented an automated inspection process, significantly improving upon the previous visual checks.
Risks Associated with Detached Components
Following a thorough assessment of the situation, Olympus prioritized addressing the risks associated with detached components, highlighting that a detached element could potentially become retained within the tracheobronchial tree. This situation can require complex medical procedures to resolve, ultimately compromising patient health.
Customer Notifications and Instructions
In light of these risks, Olympus reached out to medical professionals and facilities to alert them of the potential issues with affected lots manufactured before the new inspection standards were in place. Customers have been instructed to quarantine these devices and return them as outlined in the recall communication. Olympus emphasized the importance of adhering to existing safety protocols and device usage guidelines. Ensuring the safety of patients remains paramount.
Usage and Care Instructions
The ViziShot 2 FLEX is widely utilized with ultrasound endoscopes, facilitating ultrasound-guided fine needle aspiration (FNA) and biopsy procedures for various tracheobronchial lesions. Healthcare providers utilizing this device must remain vigilant, ensuring that any products used are not from the recalled inventory.
Standard Care Recommendations
While Olympus does not provide specific medical guidelines for patients treated with the recalled devices, it strongly advises healthcare personnel to maintain the standard post-procedure care protocols. Patients exhibiting abnormal symptoms after procedures should be evaluated for any unanticipated issues linked to device components. This evaluation is crucial as some of the components may not be visible on radiographic imaging.
Other Devices Remain Safe
It is important to note that other models of EBUS-TBNA needles are not part of this recall, ensuring that healthcare facilities can continue to use alternative devices without concerns.
Reporting Adverse Reactions
Any adverse effects or quality concerns experienced with the ViziShot 2 FLEX or other products can be reported through the FDA's MedWatch program, which facilitates tracking safety issues with medical devices. This proactive approach helps in improving patient safety and product reliability.
Contacting Olympus for Support
For further information about the recall or to report any complications associated with the use of these needles, individuals can reach out to the Olympus Technical Assistance Center at 1-800-848-9024, Option 1 for immediate assistance.
Frequently Asked Questions
What prompted the recall of the ViziShot 2 FLEX needles?
The recall was initiated due to reports of device components detaching during procedures, raising significant patient safety concerns.
What steps has Olympus taken to ensure product safety?
Olympus implemented an automated inspection procedure during manufacturing to better identify potential product defects before distribution.
Are other models of EBUS-TBNA needles affected by this recall?
No, the recall specifically targets the ViziShot 2 FLEX (19G) needles. Other models remain unaffected.
How should healthcare professionals handle the recalled devices?
Healthcare professionals are advised to quarantine any affected lots and follow the return instructions provided by Olympus.
Where can I report adverse reactions related to the ViziShot 2 FLEX?
Adverse reactions can be reported to the FDA's MedWatch program, which keeps track of safety issues for medical devices.
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