Event description: it was reported, the yellow support sheath of the device broke at the handle during a transurethral flexible ureteroscopic lithotripsy procedure.The procedure was completed with another device.The patient reportedly experienced no harm as a result of the issue.Investigation ¿ evaluation.A visual inspection of the returned device was conducted.A document-based investigation was also performed including a review of complaint history, device history record(dhr), drawing, the instructions for use, manufacturing instructions, and quality control data.One ncircle tipless stone extractor was returned for investigation.Visual exam noted the device was returned with the unidex handle (udh) separated from the basket assembly.The mlla [male luer lock adapter] was loose.Collet knob was tight and secure.The polyethylene terephthalate tubing [pett] measured 2.7 cm in length.The support sheath was severed 1 cm from base of the hub, and 4.3 cm of support sheath was still adhered to the basket sheath.The coil assembly and cannulated handle were severed at junction and 21.3 cm of coil assembly exposed from the support sheath.There was a kink in the basket sheath 6 cm, 19.5 cm, and 35.5 cm from the distal tip.The basket formation was attached to coil assembly.The remaining coil assembly was removed from basket sheath.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: 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.The returned device was found to have had the basket sheath and basket assembly separated from the handle.The provided information stated the damage occurred during use of the device.The cause for the device damage 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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