Investigation evaluation: for device one (1), the device was returned with the basket fully retracted into the sheath.During a functional test the handle was manipulated, and no movement was noted from the basket.The device was disassembled, and it was noted that the drive wire had disconnected from the handle.There was nesting of the wires inside the purple hub.For further evaluation of the drive wire cable and basket, the catheter was cut to push the drive wire cable out of the sheath.The basket was fully formed and intact, and evidence of solder was present on the handle cannula at the joint.There was an unknown yellow substance on the distal tip of the basket.No other anomalies were detected with this device.For device two (2), the device was returned with the basket fully retracted into the sheath.During a functional test the handle was manipulated, and no movement was noted from the basket.The device was disassembled, and it was noted that the drive wire had disconnected from the handle.There was nesting of the wires inside the purple hub.For further evaluation of the drive wire cables and baskets, the catheter was cut to push the drive wire cable out of the sheath.The basket was fully formed and intact, and evidence of solder was present on the handle cannula at the joint.There was an unknown white dried substance on the distal tip of the basket.No other anomalies were detected with this device.A review of the device history record could not be conducted because the lot number was not provided.Investigation conclusion: the report of unable to open the basket was due to a separation of the device in the handle.The cause of the separation is unknown.The instructions for use indicates: "advance device through channel, in short increments, until basket sheath exits endoscope." the instructions for use also states: "confirm desired position of basket sheath relative to target.Advance basket out of sheath.Caution: pulling on sheath while advancing or retracting basket may damage device, rendering it inoperable." basket deployment difficulties, and buckling/breaking of the drive wire can occur if the device experiences excessive pressure.Resistance in basket movement, and bends in the catheter can occur if the elevator of the endoscope is used to deflect the device at a sharp angle.Prior to distribution, all memory ii double lumen extraction baskets are subjected to a visual inspection and functional testing to ensure device integrity.Corrective action: 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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During an endoscopic retrograde cholangiopancreatography (ercp), the physicians used two (2) memory ii double lumen extraction baskets.After advancing a memory ii double lumen extraction basket over a wire guide, the physician attempted to deploy the basket, but the basket could not be opened.Then, another memory ii double lumen extraction basket was used instead, but the second one could not opened either.This procedure was completed without a basket catheter.There was no reportable information at this time.The devices were received for evaluation on 27 august 2020, where it was determined that the drive wires had detached from the handles of the baskets.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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