During an endoscopic ultrasound procedure, the physician used a cook echotip ultra endoscopic ultrasound needle.The user advanced the device to desired position and tried to advance the needle, but found out the handle detached from the needle length adjustment part.User changed another same device to complete the procedure.There was no reportable information at this time.The device was received for evaluation on (b)(6) 2021 and the needle could not be adjusted due to the handle being broken in two pieces.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
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Investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report.The device was returned still inside of the tray with the handle detached.The needle was fully retracted and could not be advanced due to the broken handle.The proximal end of the handle has come apart from the rest of the handle.The needle was broken into two pieces.The proximal end of the inner handle was visually examined and glue appeared to be missing from the outside of one side of the inner handle where both handle pieces attach.Handle components on the inner part of the handle were further evaluated.The cap that sits on the back of the inner handle was confirmed to be inside the proximal end of the handle.No other anomalies were detected with the device.Production meeting was held and it was confirmed that glue should be present on both sides of the proximal end of the inner handle.The device history record for the subassembly of the handle assembly and the finished device lot number said to be involved were reviewed.A discrepancy or anomaly was not observed with the product that was released for distribution.Investigation conclusion: the root cause of the handle separation is an inadequately glued joint, as it was confirmed that the handle sheath was missing glue on one side.This most likely happened during the handle assembly process.Production management and the department team leads were notified of this occurrence.Prior to distribution, all echotip ultra endoscopic ultrasound needles are subjected to a visual inspection and functional testing to ensure device integrity.A review of the device history record confirmed that the lot said to be involved met all manufacturing requirements prior to shipment.Corrective action: a review of the complaint history was conducted.The likelihood of occurrence is considered rare.Corrective action is not warranted at this time based on the quality engineering risk assessment.Quality assurance will continue to monitor for complaint trends and reassess the risk assessment results as post market feedback continues to become available.
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