Blank fields on this form indicate the information is unknown or unavailable.E1- (b)(6).G4- pma/510(k) #: exempt.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.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 or that a death or serious injury occurred; nor is it admission 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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Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Event summary it was reported that the distal end of two gage nitinol stone extractor baskets detached during a stone removal procedure and were unable to be opened.The user changed to a new same device to complete the procedure.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.Investigation ¿ evaluation a document-based investigation was performed including a review of complaint history, device history record (dhr), instructions for use (ifu), manufacturing instructions (mi) and quality control procedures, as well as a visual inspection of the device were conducted.Two ngage nitinol stone extractors were returned in marketing boxes with labels.Upon inspection both basket formations have wires pulled free from the shrink tube and basket sheath.A document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the dhr for the reported complaint device lot revealed no confirmed recorded non-conformances relevant to the failure mode.A review of complaints with the same lot number shows 3 other complaints had been reported.Two of the three other recorded complaints are for the same failure mode as this complaint.The information provided upon review of complaint file, device history record, complaint history, and quality control documents did not provide evidence to support that the device was manufactured out of specification or to suggest items in the lot or similar devices in the field or in house were nonconforming.Cook also reviewed product labeling.The product ifu, t_shef_rev1; the ifu did not provide any information related to the reported issue.Based on the information provided, inspection of the returned device, and the results of the investigation, a cause had not been determined.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the risk assessment 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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