WILSON-COOK MEDICAL INC MEMORY HARD WIRE BASKET; FFL, DISLODGER, STONE, BASKET, URETHRAL, METAL
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Model Number G57268 |
Device Problems
Difficult to Remove (1528); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Foreign Body In Patient (2687)
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Event Date 08/02/2022 |
Event Type
Injury
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Event Description
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During an endoscopic retrograde cholangiopancreatography (ercp), the physician used a cook memory hard wire basket.It was reported that the basket with stone became stuck & would not traverse the ampulla.According to the initial reporter, the physician cut handle off, removed the scope, transferred the patient to a facility with advanced lithotripsy and the patient was reported to not have experienced any adverse effects due to this occurrence.
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Manufacturer Narrative
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Investigation evaluation: a product evaluation was not performed in response to this report because the product said to be involved was not provided to cook for evaluation.The report could not be confirmed.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: we could not conduct a complete investigation because the product said to be involved was not returned for evaluation.A definitive cause for the reported observation could not be determined.However a device failure was not reported in the article.The instructions for use includes the following potential complications: "others potential complications associated with biliary stone or foreign body removal include, but are not limited to: impaction of the object, aspiration of the foreign body, localized inflammation, pressure necrosis, perforation and ductal trauma." prior to distribution, all memory hard wire 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: 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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Search Alerts/Recalls
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