COOK ENDOSCOPY MEMORY II DOUBLE LUMEN EXTRACTION BASKET; FFL, DISLODGER, STONE, BASKET, URETHRAL, METAL
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Catalog Number MB-35-2X4-8 |
Device Problems
Fracture (1260); Material Separation (1562)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
malfunction
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Manufacturer Narrative
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Investigation evaluation: our laboratory evaluation of the product said to be involved determined the drive wire disconnected from the handle.The device was returned with the basket fully retracted and a clear liquid inside of the tubing.The basket would not move when the handle was manipulated and noted that the handle seemed loose.The device was disassembled and it was noted that the drive wire disconnected from the handle and nesting was in the purple hub.For further evaluation of the drive wire cable and basket, the catheter was cut to attempt to push the drive wire cable out of the purple hub.The handle cannula was discovered to be stuck within the purple hub and could not be dislodged.The basket was fully formed and intact, and evidence of solder was present on the handle cannula at the joint.The device history record for the lot number said to be involved was reviewed.A discrepancy or anomaly was not observed with the product that was released for distribution.Investigation conclusion: a definitive cause for this observation could not be determined because the actual use conditions could not be duplicated in the laboratory setting.Due to a variety of clinical conditions such as patient anatomy, endoscope position or progression of disease state, we could not reproduce the actual conditions of product usage during our laboratory analysis.This limits our ability to conclusively determine a cause.The instructions for use 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." the instructions for use also indicates: "advance device through channel, in short increments, until basket sheath exits endoscope." 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.A review of the device history record confirmed that the lot said to be involved met all manufacturing requirements prior to shipment.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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Event Description
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During an endoscopic retrograde cholangiopancreatography (ercp) procedure, the physician used a cook memory ii double lumen extraction basket.During the procedure the physician could not open the basket.Another cook basket was used to complete the procedure.This event was not reportable at the time.The device was received on 25-feb-2020 and it was noted the drive wire was separated from the handle.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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Search Alerts/Recalls
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