Blank fields on this form indicate the information is unknown or unavailable.E1- customer (person): postal code: (b)(6) // phone:(b)(6).E3- occupation: theatre support officer.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.Correction: d10, h6 annex g summary of event: it was reported that the basket wires of an ngage nitinol stone extractor detached from the basket sheath prior to a planned procedure.Device was not used in the patient.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.Investigation evaluation: reviews of the complaint history, device history record (dhr), instructions for use (ifu), manufacturing instructions (mi) and quality control (qc) procedures were conducted during the investigation.A visual inspection was conducted as well.The complaint device was returned to cook for investigation.The basket formation had separated from the distal end of the basket sheath.A document-based investigation evaluation was performed.Three related non-conformances were noted.However, all affected product was scrapped and there are 100% inspections in place to capture the non-conformance.One other complaint had been reported for this lot.The two complaints are related.The product ifu [t_shef_rev1] did not provide any information related to the reported issue.Adequate inspection activities had been established, and there was objective evidence that the dhr was fully executed there was not sufficient evidence to conclude that nonconforming product exists in house or in field.The information provided upon review of the dmr, dhr, ifu, returned device, and complaint file suggests that there is evidence the device was manufactured to specification.There is no evidence of non-conforming devices in-house or in the field.Based on the information provided and the results of the investigation, cook has concluded that a cause could not be determined.Per the quality engineering risk assessment, no further action is required.The appropriate personnel have been notified, and 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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