It was reported, during a urinary bladder stone removal procedure using a ncircle tipless stone extractor, the wire near the handle broke in two.The device was used several times, but then the user felt the device get stuck.The device was removed from the endoscope.It was discovered that the 'wire of catheter near the handle' was broken in two.The procedure was completed successfully with another new device.A section of the device did not remain inside of the patient's body.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
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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, drawings, the instructions for use, manufacturing instructions, and quality control data.One device was returned for investigation.Visual inspection of the returned device found that it was returned with the handle in the open position and separated from the catheter.The basket formation was retracted within the catheter.The catheter measured 65.2 cm.The point of separation was angled and stretched in appearance.It was noted that 2 cm of the coil was protruding from the catheter.The coil and cannulated handle was found to be severed.The solder was not visible where the coil and cannulated handle were severed.A review of the device history record 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 lot related complaints that have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field.A lot history search found one other complaint had been reported for this lot.Investigation of both complaint devices did not determine that the cause was related to manufacturing, therefore the other devices in the lot are not suspect.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 returned device was found to have the basket assembly and basket sheath separated from the handle.The provided information stated the issue occurred during use.Based on the extent of the device damage, it was inadvertently exposed to excessive force during use, which caused the basket assembly and basket sheath to separate from the handle.Cook has concluded that the cause of this damage was unintended use error.Per the quality engineering risk assessment, no further action is warranted.Cook 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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