As reported, after opening the package of a nforce nitinol helical stone extractor, it was found that the metal wire in the front of the casing at the handle was broken.The procedure was completed by using another new device.No adverse effects to the patient have been reported.
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Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Event summary as reported, after opening the package of a nforce nitinol helical stone extractor, it was found that the metal wire in the front of the casing at the handle was broken.The procedure was completed by using another new device.No adverse effects to the patient have been reported.Investigation - evaluation reviews of the complaint history, device history record, instructions for use, manufacturing instructions, and quality control procedures and a visual inspection and functional test of the device were conducted during the investigation.The device was returned for investigation in opened packaging.The collet and male luer lock adapter were tight.There was an area of damage on the basket sheath approximately 8cm from the end of the male luer lock adapter.The black cover appeared scraped.The handle did not actuate the basket assembly.The polyethylene terephthalate tubing was missing.A document-based investigation evaluation was performed.No related non-conformances were recorded.No additional complaints were received for this product lot.The device history record review provides objective evidence that the device was manufactured to specification.There is no evidence of nonconforming devices from the complaint lot in house or in the field.A review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was functionally inspected by quality control and no notable gaps in production or processing controls were noted.There is no indication that a design or process related failure mode contributed to the reported event.Sufficient inspection activities are in place to identify this failure mode prior to distribution.The device is provided with instructions for use which caution, ¿do not use excessive force to manipulate this device.Damage to the device may occur.¿ based on the available information, cook has concluded that a cause for this event could not be established.Excessive force may have been inadvertently applied to the device.No information related to device handling is known, however, and a thus a cause could not be definitively determined.Cook will continue monitoring of similar complaints and has notified the appropriate personnel of this event.Per a review of risk documentation, no further action is required.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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