As reported, during transurethral lithotripsy (tul), the user inserted a ncircle tipless stone extractor into the scope and opened the basket once and the basket would not close.There was nothing with the patient¿s anatomy keeping the basket from opening or closing.Another same type device was used to complete the procedure.The patient did not experience any adverse effects due to this occurrence.
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Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Event summary: as reported, during transurethral lithotripsy (tul), the user inserted a ncircle tipless stone extractor into the scope and opened the basket once and the basket would not close.There was nothing with the patient¿s anatomy keeping the basket from opening or closing.Another same type device was used to complete the procedure.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 product was returned in opened packaging with plastic clamshell.The handle would not actuate the basket.The handle was removed to be examined.The collet knob was overly tight and when removed, it appeared to be damaged.The metal piece that holds the cannula in place and attaches to the collet knob disbursed a black foreign matter when removed, and appears to have a white substance inside.The basket could be actuated manually.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 three 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: enclose the device in the sheath before removing from the tray/holder.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 complaint device was found to have a basket that was opened and could not be closed.The device was disassembled and it was found the basket could be manually opened and closed with the device handle removed.Investigation of the handle found damage.It was difficult to remove the black collet knob on the proximal end of the device, and plastic pieces of both the collet knob and handle were observed inside the collet, and in the proximal end of the handle.It was likely that the debris found inside the handle was preventing normal motion.The cause for the debris 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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