The reported event was confirmed.Visual evaluation of the sample noted one opened (without original packaging) skylite nitinol stone basket.It was noted that the basket slide was detached from the stone basket handle.The assembly was not conforming to regulations and was out of specification.After reassembling the basket slide back onto the stone basket, the device functioned properly.Although the reported event was confirmed, the root cause could not be determined.A potential root cause for this failure could be "lack of epoxy / adhesive / cure time." the device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: " "precautions: before using, inspect for any breach of packaging to ensure sterility of product.Do not use if breach in sterile barrier is obvious or suspected.Do not allow the device to come in contact with any electrified instruments or laser.Kinks in the sheath will hinder the mechanical operation of the basket, may affect insertion or withdrawal of the basket and has the potential to damage the endoscope¿s instrument channel.Do not allow the device to be directly fired upon by any lithotripsy devices.To do so may result in damage to the device and could result in patient injury.Potential complications that may result from the use of a basket in an endoscopic urological procedure include, but are not limited to: ¿ perforation ¿ evulsion ¿ edema ¿ entrapment ¿ laceration ¿ basket inversion ¿ hemorrhage ¿ inability to disengage from irretrievable object".
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