It was reported that during a stone extraction procedure, the ncircle delta wire tipless stone extractor basket would not open and close properly.After the patients lithotripsy procedure, the user advanced the basket into the channel of the flexible ureteroscope, it was then noted that the basket would not open and close as intended.The device was removed and a new basket was used for the procedure.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.
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Event summary: it was reported that during a stone extraction procedure, the ncircle delta wire tipless stone extractor basket would not open and close properly.After the patients lithotripsy procedure, the user advanced the basket into the channel of the flexible ureteroscope, it was then noted that the basket would not open and close as intended.The device was removed and a new basket was used for the procedure.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.Device was returned in the opened original packaging.The black knob was tight with 18mm of basket wire poking through, and the white knob was loose.The spacer was present.The handle did not actuate smoothly, requiring force to minimally open and close the basket.After a few cycles of actuation, there was a noticeable difference in the basket shape in relation to the handle position.The black knob was loosened and the handle segment of the basket wire fell out.This presumably broke during one of the actuation cycles used to test the functionality of the device.Magnified images of the basket cannula indicate a ductile fracture of the metal via necking given the cup-like appearance of the fractured end.Upon disassembly of the white knob, it was found that the support sheath was separated.A review of the device history record (dhr) found no non-conformances related to the reported failure mode.A review of complaint history records shows no other complaints associated with the complaint device lot.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.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.Based on the available information, cook has concluded cause for the reported device failure 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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