WILSON-COOK MEDICAL INC MEMORY II DOUBLE LUMEN EXTRACTION BASKET; LQR DISLODGER, STONE, BILIARY
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Catalog Number MB-35-2X4-8 |
Device Problems
Difficult to Fold, Unfold or Collapse (1254); Material Separation (1562)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/26/2022 |
Event Type
malfunction
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Event Description
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During a common bile duct stone extraction, the physician used a cook memory ii double lumen extraction basket.It was reported that the basket would not open in the target site in the common bile duct.There was no reportable information at this time.The device was received for evaluation on 10/03/2022.It was discovered that the drive wire was detached from the nesting in the purple hub.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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Manufacturer Narrative
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Investigation evaluation: the product said to be involved was returned in an open pouch from the lot number provided in the report.The label matches the product returned.Our laboratory evaluation of the product said to be involved confirmed the report.The device was returned with the basket fully retracted into the catheter with a clear liquid present in the catheter.The handle was manipulated with no movement from the basket.The handle was disassembled, and it was noted that the drive wire was separated from the handle with nesting of the wire inside the purple hub.During evaluation, a portion of the distal catheter was removed to expose the basket.The basket was fully formed and intact.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: 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.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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Search Alerts/Recalls
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