Adverse Event reported on 6/21/2013

Device Attributes
Product CodeLQC
Model Number
Catalog NumberSLH-1
Device Operator0HP
Catalog Number SLH-1
Device Problems Accessory incompatible; Break; Improper or incorrect procedure or method
Event Date 05/15/2013
Event Type  Malfunction  
Manufacturer Narrative

Investigation evaluation: our evaluation of the returned device confirmed the report. The distal bar was broken in half where the threaded hole is located. The luer adapter was missing from the threaded hole in the distal bar. The flat side bars were bent at the distal end. A visual examination determined that based on the materials used in this device it was manufactured before october 1998. Given the age of the device and the cyclic loading of multiple procedures the device encountered during that time frame the device has experienced end of life metal fatigue. A product-specific discrepancy that could have caused or contributed to this observation was not observed during our laboratory analysis. A review of the device history record could not be conducted because the lot number was not provided. Investigation conclusions. Based on the materials of the returned device iw as manufactured before october 1998. Given the age of the device and the cyclic loading of multiple procedures encountered over that time frame the device has experienced end of life metal fatigue. The instructions for use states: "warnings: only select cook biliary soft wire baskets are recommended for use with this device. Do not remove sheath from basket wire. Doing so may result in basket fragmentation and consequently require surgical intervention. Due to mechanical pressure generated with this device, basket fragmentation in common bile duct is a possibility that may require surgical intervention. " the instructions for use states: "potential complications: those associated with basket extraction include but are not limited to impaction of object. The instructions for use also states: "reusability of device depend in a large part on care of device by user. Factors involved in prolonging life of this device include, but are not limited to: through cleaning following instructions included in this booklet. During cleaning, inspect integrity and function of device to determine advisability of reuse. If kinks, bands or breaks exist, do not use. Prior to distribution, all cook devices are subjected to a visual inspection and functional 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 information 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.

Event Description

During an endoscopic retrograde cholangiopancreatography (ercp) in the liver, the physician captured a stone with a basket made by another company. The wire of the basket was cut and the outer sheath was removed. The duodenoscope was removed. The cook soehendra cable was placed over the wires from the basket and the wire was then mounted on the cook soehendra handle. During lithotripsy the cook soehendra lithotripsy handle broke. A new handle made by another company was used and the wire of the basket broke. The patient had to go to surgery for removal of the stone and basket. The patient did require surgery because the basket (not made by cook) broke during lithotripsy with another company's lithotripsy handle. The patient had to go to surgery to remove the stone and basket. According to the initial reporter, the patient did not experience any adverse effects due to the occurrence with the cook sohendra lithotriptor handle.

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Source: FDA