Olympus (omsc) was informed by the physician at the user facility that the disposable grasping forceps was being used to remove common bile duct stones via a cholangioscope (chf-v) during a laparotomy procedure, ¿reports of events such as the wire at the root being cut or the basket being unable to open and close when pulled lightly immediately after opening is receiving.¿the procedure was completed using another device (fg-52d).No death, injury or harm was reported to olympus.
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This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The subject device was returned and an evaluation completed for it.The evaluation confirmed the users complaint.In the replication testing, the following phenomena have been confirmed in the products with greater force to open and close the basket than the standard value: compressive buckling or breakage occur when the basket is opened and closed continuously.The basket cannot be opened or closed due to breakage or buckling of the tube.Based on the lot number of the device the manufacturing month and year were reported in h4.The specific date could not be made available at this time.Based on the results of the investigation, the exact cause could not be determined due to the following reasons: since the tubes of the subject devices were broken, a force to open and close the basket could not be inspected.The details surrounding the event were unknown.It can be concluded that either the product did not meet the specifications or device handling might have contributed to the reported phenomenon.A likely mechanism causing the reported event might be the following: a force to open and close the basket was greater than the standard value.Therefore, a compression force was applied to the tube when operating (open/close) the basket.The tube was buckled compressively near the black tube.Repeatedly operating the ring made the compressively buckled part to stretch and tear.Due to breakage of the tube, the basket could not be opened.The event can be detected/prevented by following the instructions for use which state the following: "do not coil the insertion portion with a diameter of less than 15 cm.This could damage the insertion portion." "never use excessive force to open or close the grasping portion.This could damage the instrument." "when the grasping portion does not open and/or close smoothly, do not apply force but set the scope¿s angle back, or move the position of the grasping portion until the basket opens and closes smoothly.If the action is forced, the tube may stretch and the resistance of the handle may increase.Also the calculus may not be retrieved, and/or the grasping portion with calculus engaged may not be removed from the body." olympus will continue to monitor field performance for this device.
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