WILSON-COOK MEDICAL INC. MEMORY II DOUBLE LUMEN EXTRACTION BASKET; FFL, DISLODGER, STONE, BASKET, URETHRAL , METAL
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Catalog Number MB-35-2X4-8 |
Device Problems
Unintended Collision (1429); Material Separation (1562); Improper or Incorrect Procedure or Method (2017)
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Patient Problems
No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)
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Event Date 01/14/2014 |
Event Type
Injury
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Event Description
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During a gallbladder stone removal procedure, a cook memory ii double lumen extraction basket was used.The physician captured the gallbladder stone and attempted to remove the stone, but the device got stuck at the cystic duct.The physician used a cook soehendra lithotripsy handle (slh-1) and a conquest ttc lithotriptor cable with adapter (ttcl-1) to remove the device carefully, but the wire [drive wire] broke near the patient's mouth.The physician placed a nasal drainage tube and the broken drive wire is out from the nose with the tube.A cholecystectomy procedure was performed and the gallbladder was removed along with the basket.According to the initial reporter, the pt did not experience 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.A review of the device history record could not be conducted because the lot number was not provided.Investigation conclusions: we could not conduct a complete investigation because the product said to be involved was not returned for evaluation.A definitive cause for the report observation could not be determined.The instructions for use for this device state: "warning: this device is not compatible with the soehendra lithotriptor or any other mechanical lithotriptor." stone removal; "caution: if difficulty is encountered when removing basket from duct, moderate force may be applied by pulling on handle to manually fracture stone.If passage is still restricted, surgical intervention may be necessary." according to the initial reporter a soehendra lithotripsy handle was used during the procedure which is against the instructions for use.The instructions for use for this device state: "this device is designed for single use only.Attempts to reprocess, resterilize, and/or reuse may lead to device failure.Visually inspect with particular attention to kinks, bends and breaks.If an abnormality is detected that would prohibit proper working condition, do not use." the instructions for use for this device state: "if device is to be used for biliary stone extraction, contraindications include an ampullary opening inadequate to allow for unimpeded passage of the stone and basket.Surgical intervention may be required if impaction occurs." prior to distribution, all cook memory ii double lumen extraction baskets are subjected to a visual inspection and function testing to ensure device integrity.Corrective action: a review of the complaint history was conducted and this represents an unusual occurrence.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.Additional comments regarding this report: based on the info provided, a cook representative has been directed to contact the medical facility involved in an effort to promote further education and understanding related to appropriate usage of this product.
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