Medical device manufacturer, Olympus, has issued a medical device safety alert concerning its Olympus Pleuravideoscope LTF-160 and LTF-240 [Serial Number: All]. The Pleuravideoscope LTF-160 and LTF-240 are indicated for use for endoscopy and endoscopic diagnosis and treatment within thoracic cavity.
The manufacturer informed that the combination of the below listed Endo-therapy accessories with the LTF-160 and LTF-240 did not pass the recent compatibility assessment. If these devices are used in combination within the thoracic cavity, the efficacy (such as the amount of the tissue collected/coagulated or the amount of injection) may be lower than the users expect or minor injuries (scratches or minor bleedings) may occur inside the patient's body. The manufacturer did not receive any report of injury with the LTF-160 and LTF-240 Pleuravideoscopes used in combination with the Endo-therapy accessories.
In an effort to maximize patient safety and mitigate any potential risk to patient health, the manufacturer is notifying users of the incompatibility of the below listed Endo-therapy accessories to Pleuravideoscopes LTF-160 and LTF-240 and requires users to immediately stop using the LTF-160 and LTF-240 in combination with the below listed Endo-therapy accessories except for Biopsy forceps FB-55CR-1.
Incompatible Endo-therapy accessories to LTF-160 and LTF-240:
These Endo-therapy accessories may be used with other Olympus endoscopes if the Instruction for Use of the device states the compatibility with such other endoscope (GIF, CF, BF and others). The Biopsy forceps FB-55CR-1 remains compatible to the LTF-160 and LTF-240.
According to the manufacturer, the affected users are advised to do the following actions:
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 30 July 2020