The scope and the biopsy cap were returned to olympus for evaluation.The evaluation confirmed the reported event.A visual inspection found the rubber cap damaged.In addition, the scope¿s biopsy channel was found leaking.There was a tear mark found inside the biopsy channel wall that likely contributed to the leak.The light guide lens was also found cracked.The scope was serviced and returned to the user facility.Based on the evaluation findings, the cause of the damaged biopsy cap is likely due to user handling / excessive force when inserting an accessory instrument through the biopsy cap.The instruction manual for use provides warning statements in an effort to prevent damage to the biopsy cap.¿slowly insert or withdraw the endotherapy accessory straight into or from the slit of the biopsy valve.Otherwise, the biopsy valve may be damaged and pieces of it could fall off.Inserting or withdrawing endotherapy accessories with excessive force may damage the instrument channel or endotherapy accessories and could cause some parts to fall off and/or cause patient injury.¿.
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