Catalog Number 2B5LT |
Device Problem
Bent (1059)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.The device history records were reviewed and the manufacturing criteria were met prior to the release of this lot.
|
|
Event Description
|
It was reported that during an unknown procedure the shaft of the trocar appeared to be bent and it was difficult to pull the device through the cannula.It was unknown how the procedure was completed.
|
|
Manufacturer Narrative
|
(b)(4).It was concluded that this event does not meet the fda defined criteria for a reportable event and is being considered not reportable.
|
|
Search Alerts/Recalls
|