COOK ENDOSCOPY MEMORY II DOUBLE LUMEN EXTRACTION BASKET; FFL, DISLODGER, STONE, BASKET, URETHRAL, METAL
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Model Number G25149 |
Device Problem
Fracture (1260)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 09/05/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Concomitant medical products: boston scientific jagwire; unknown model.Investigation conclusion: our laboratory evaluation of the product said to be involved confirmed the report.The basket would not move when the handle was manipulated.The device was returned with the basket fully retracted and clear fluid present in the lumen.Although the handle could move during functional testing, the basket does not advance/retract with handle movement.There was a grinding sound/feeling with handle manipulation.The handle was disassembled and it was noted that the drive wire was separated from the cable.Nesting was noted inside the purple hub.The portion of drive wire cable remaining attached to the handle cannula had nested (bunched up against the handle cannula).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 is fully formed.The drive wire cable from inside the sheath has nested.Solder is present on the handle cannula and drive wire cable at the joint.No other anomalies were detected with the device.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.Basket advancement/retraction difficulties and nesting 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.The instructions for use indicate: "advance device through channel, in short increments, until basket sheath exits endoscope." the instructions for use state: "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." 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), the physician used a cook memory ii double lumen extraction basket (mb-35-2x4-8).The physician removed the stones and sludge by using the mb-35-2x4-8 and another manufactures wire guide.For additional sweeping in the duct, the physician inserted the basket into the duct.The nurse tired to push the handle, but couldn't.The handle did not move and the basket did not come out of the sheath.So, they had to use the new mb-35-2x4-8.There was no reportable information at this time.The device was evaluated on 17-sep-2108 and it was determined that the drive cable was disconnected from the drive wire.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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