| Reason for the Action |
Olympus is currently investigating an increase in complaints associated with rubber fragment detachment in the slit of MAJ-210 Single use Biopsy Valve.
While the investigation regarding the cause of the issue is ongoing, Olympus is highlighting the importance of strictly adhering to the ‘Inspection of the Biopsy Valve’ and ‘Inserting and Withdrawing the Endo-therapy accessories’ sections in the IFU related to the detachment of fragment from the slit part of rubber.
Potential consequences associated with detachment of fragment(s) from the MAJ-210 biopsy valve include several possible patient harms. The most common harm is the presence of a foreign body in the patient’s tracheobronchial tree, which may require intervention for removal. In all reported cases, the detached fragment(s) was identified immediately during the bronchoscopy procedure, with the majority successfully removed using bronchoscopic suction or standard bronchoscopic tools. However, some cases noted unconfirmed retrieval, unsuccessful retrieval, or fragments displaced to the gastrointestinal tract following patient coughing. Although not reported, unintended retention of device fragments could potentially lead to an inflammatory response in the patient. Additional risks include a potential decrease in suction capability during the procedure due to a detached fragment, which could result in accumulation of patient secretions, potentially leading to hypoxia and further extending procedure duration. |