Event summary: it was reported that an ncircle tipless stone extractor package was opened and tested prior to use/patient contact for a ureteroscopy.At the time of testing it was noted that the extractor would not open/close.A new device was opened and used successfully to complete the case.A section of the device did not remain inside the patient¿s body.The patient did not require any additional intervention due to this occurrence.The patient did not experience any adverse effects due to this occurrence.Investigation ¿ evaluation: a visual inspection and functional testing of the returned device was conducted.A document-based investigation was also performed including a review of complaint history, device history record, the instructions for use, manufacturing instructions, and quality control data.A device failure analysis was conducted on the returned device.The investigator made the following notation: product was returned in open packaging.The basket could not be actuated using the handle.As seen in the video, it appears that the cannula was not attached or secured at the proximal end.All fittings appeared tight.No bends or kinks in the basket sheath, a slight curve is noted in the support sheath.The handle was disassembled, and was able to manually actuate the basket.The reported failure mode was confirmed, unable to determine cause.A review of the device history record (dhr) found no non-conformances related to the reported failure mode.Because there are no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other related complaints from the lot have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field.A review of complaint history records shows no other complaints associated with the complaint device lot.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: precaution: do not use excessive force to manipulate this device.Damage to the device may occur.A review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was visually/functionally inspected by quality control and no related gaps in production or processing controls were noted.The returned device was found to have a basket that was open and could not be closed.The cannulated handle (the proximal end of the basket assembly) had pulled free from the collet (the handle component that secured the basket assembly to the handle).This allowed the basket assembly to move distally inside the basket sheath, resulting in the open basket that could not be closed.All fittings, which included the collet knob were found to be tight, indicating the device was properly assembled.The cause for the separation of the cannulated handle from the collet could not be determined.Per the quality engineering risk assessment, no further action is warranted.Cook medical will continue to monitor this device via the complaints database for similar complaints.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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