It was reported, the basket wire of the 'ngage nitinol stone extractor' detached from the cannula, prior to a cystoscopy right ureteroscopy laser lithotripsy right ureteral stent exchange.The device did not make patient contact.The procedure was said to be successfully completed.A laser was used during the procedure, and tortuous, calcified, or scarred patient anatomy was denied.As reported, the patient did not have any adverse effects reported or additional procedures required.
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Blank fields on this form indicate the information is unknown or unavailable.G4: pma/510(k) number = 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 unchanged, unknown, or unavailable.Correction: h6 (annex g).Investigation ¿ evaluation.It was reported the basket wire of the 'ngage nitinol stone extractor' detached from the cannula, prior to a cystoscopy right ureteroscopy laser lithotripsy right ureteral stent exchange.The device did not make patient contact.The procedure was said to be successfully completed.A laser was used during the procedure; tortuous, calcified, or scarred patient anatomy was denied.The patient did not have any adverse effects reported or additional procedures required.Reviews of the complaint history, device history record (dhr), instructions for use (ifu), manufacturing instructions, and quality control procedures, as well as a visual inspection and functional test of the returned device, were conducted during the investigation.The returned device was found to have a basket that would not open due to separation of the basket from the basket sheath.The shrink tube and glue that secures the basket to the basket sheath had not held the two components together.The basket assembly is manufactured by a supplier; and an investigation was created to assess the issue.Additionally, a document-based investigation evaluation was performed.In response to this incident, cook completed a review of the product device master record (dmr) and concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.Cook also reviewed the dhr for the reported lot.One possibly related nonconformance was recorded for "shrink tube, damaged".A database search for complaints on the reported lot found no additional complaints reported from the field.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, 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.Per the risk assessment no further action is required.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.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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