|
Catalog Number NGE-017115 |
Device Problem
Detachment of Device or Device Component (2907)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 11/17/2023 |
Event Type
malfunction
|
Event Description
|
As reported, during ureteroscopic laser lithotripsy, the basket wire of the ngage nitinol stone extractor was found to be detached by the user during the procedure.Another device of the same type was used to successfully 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.
|
|
Manufacturer Narrative
|
Blank fields on this form indicate the information is unknown or unavailable.E1: customer phone = (b)(6).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.
|
|
Event Description
|
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
|
|
Manufacturer Narrative
|
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Correction: h6 (annex g) investigation ¿ evaluation as reported, during ureteroscopic laser lithotripsy, the basket wire of the ngage nitinol stone extractor was found to be detached by the user during the procedure.Another device of the same type was used to successfully 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), manufacturing information (mi), and quality control procedures, as well as a visual inspection of the device were conducted.One ngage nitinol stone extractor was returned in an open package with label.Wires from the basket formation pulled free from 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 confirmed recorded non-conformances related to the failure mode.A lot history search found 5 complaints had been reported for this lot.All complaints were for the same issue.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 has 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.
|
|
Search Alerts/Recalls
|
|
|