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Investigation ¿ evaluation: event description: cook was informed of an incident involving a ngage nitinol stone extractor nge-017115.
The device reportedly couldn¿t be retrieved before use during an unspecified procedure.
Attempts to acquire additional information from the user facility were executed, however no additional information was provided to cook in response to this incident.
A visual inspection of the returned device was conducted.
A document based investigation was also performed including a review of complaint history, the device history record, instructions for use, manufacturing instructions, and quality control data.
Device failure analysis: the complainant returned one ngage nitinol stone extractor.
The device was returned with handle in the open position and the basket formation in the open position, the mlla [male luer lock adapter] was tight.
Collet knob is tight and secure.
Visual exam noted a small kink in basket sheath 87.
5 cm from distal end.
Visual exam notes support sheath and basket sheath are no longer attached.
Visual exam notes glue is visible.
Visual exam note basket formation is intact.
A lot history search found no other complaints have been reported for this lot.
A review of the device history record revealed no non-conformances related to the reported failure.
Because there are no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot related complaints that have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field.
Cook also reviewed product labeling.
The product ifu for this device provides the following information: suggested handling instructions for extractors and forceps.
Caution: this device is conductive.
Avoid contact with any electrified instrument.
Caution: sterile if the package is unopened or undamaged.
Do not use if package is broken.
Caution: federal (u.
S.
A.
) law restricts this device to sale by or on the order of a physician.
Important: enclose device in sheath before removing from tray/holder.
Important: excessive force could damage device.
Store in a dark, cool, dry place.
Device master record (dmr) review: in response to this incident, cook completed a review of the product dmr.
Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.
Conclusion: the returned device was found to have a basket that was opened and could not be closed due to sheathe separation.
The basket sheath and support sheath were no longer connected, preventing the basket from functioning.
The basket sheath and support sheath are glued together during manufacturing.
Glue reside was observed on the basket sheath, indicating proper assembly.
All devices are tested multiple times for damage and functionality during manufacturing and quality control checks.
It is possible that while unpacking the device, or during subsequent handling, the device experienced excessive force that caused the two sheath components to separate.
There is no information regarding device handling, therefore the cause for the issue could not be conclusively determined.
The information provided upon review of complaint file, device history record, complaint history and quality control documents do 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 are nonconforming.
The risk documentation procedures were reviewed, and it was determined that no actions are required.
Cook 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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