It was reported prior to using a ncircle tipless stone extractor during an endoscopic lithotomy procedure, the user opened the package and found that one of the wires of the basket was broken.The user experienced no difficulties removing the device from the package, and no visible damage was noted to the product packaging.The complaint device was not used, and the procedure was completed using new device.There were no adverse effects to the patient as a result of this occurrence.
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Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Investigation ¿ evaluation: it was reported, the device was found to have a broken basket wire.A second device was used to complete the procedure.The patient reportedly experienced no harm as a result of the issue.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, drawing, manufacturing instructions, the instructions for use, and quality control data.One ncircle tipless stone extractor was returned for investigation.Inspection of the returned device noted: the device was returned with the handle and basket formation in the open position.The mlla [male luer lock adapter] was tight and the collet knob was loose.The cannulated handle had slipped out of the collet knob.One wire in the basket formation was pulled out of the distal cannula.The device shows evidence of being used.The basket wire that was separated appears to have been hooked on something and pulled out of the cannula.Functional testing determined the handle does not actuate the basket formation.A review of the device history record 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 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.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 1 of the basket wires pulled free from the basket cannula at the proximal end of the basket that holds the wires in place.It was also found that the basket was open and could not be closed.The device appears to have been used, contrary to the provided information that the issue occurred before use.There is not enough information available to make a determination of the cause of the issue.The risk analysis for this failure mode was reviewed, and it was determined that no further action is required.We will continue to monitor 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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