As reported, during a ureteroscopy, the user detected that the basket could not be opened before use.Another same device was used to complete the procedure.No section of the device remained inside the patient's body.The patient did not require any additional procedures due to this occurrence.The complainant has not reported any adverse effects on the patient due to this occurrence.
|
G4: pma/510(k) number = exempt h3: device has been returned and preliminary evaluation has been performed, however, our investigation is ongoing and device evaluation summary will be included in our follow up report once our investigation has been completed.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.
|
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Correction: h6 (annex g).Investigation ¿ evaluation as reported, during a ureteroscopy, the user detected that the basket could not be opened before use.Another same device was used to complete the procedure.No section of the device remained inside the patient's body.The patient did not require any additional procedures due to this occurrence.The complainant has not reported any adverse effects on the patient due to this occurrence.A document-based investigation was performed including a review of complaint history, device history record (dhr), instructions for use (ifu), manufacturer instructions (mi), and quality control procedures, as well as interview personnel, a visual inspection and a functional test of the device were conducted.One ngage nitinol stone extractor was returned to cook for evaluation in opened packaging.The basket wires pulled free from 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 confirmed recorded non-conformances relevant to the failure mode.A database search identified three other complaints associated with the reported device lot.Three of the (b)(4) complaints were for a related issue, separation of the basket from the basket sheath.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 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.
|