As reported, prior to use for an unknown procedure upon opening the packaging the user found an ngage nitinol stone extractor's basket did not open.The device did not make patient contact.Another same type device was used to complete the procedure.It was reported, that the patient did not require any additional procedures or experience any adverse effects due to this occurrence.
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Blank fields on this form indicate the information is unknown or unavailable.E1: address: (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, 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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Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Correction: h6 (annex a and annex g).Investigation ¿ evaluation as reported, prior to use for an unknown procedure upon opening the packaging the user found an ngage nitinol stone extractor's basket did not open.The device did not make patient contact.Another same type device was used to complete the procedure.It was reported, that the patient did not require any additional procedures or experience any adverse effects due to this occurrence.Reviews of the complaint history, device history record (dhr), instructions for use (ifu), manufacturing instructions (mi), and quality control, as well as a visual inspection of the returned device, and interviewing personnel were conducted during the investigation.One ngage nitinol stone extractor was returned in an open package with label.Visual exam notes the basket was not secured to the distal end of the basket sheath.The shrink tube and glue that secures the basket to the basket sheath had not held the two components together.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 recorded non-conformances relevant to the failure mode.A database search identified one other complaint associated with the reported device lot.This recorded complaint is not related to the current failure mode.Because there were no related non-conformances, adequate inspection activities had been established, there was objective evidence that the dhr was fully executed, and no other related complaints from the lot had been received from the field, it was concluded that there was no evidence that nonconforming product exists in house or in field.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 basket assembly is manufactured by a supplier.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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