Catalog Number EPS01 |
Device Problems
Break (1069); Material Twisted/Bent (2981)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 08/04/2019 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).Date sent: 9/4/2019.Batch # r93t69.Investigation summary: the instrument was received with the electrode tip bent and not detached as reported.In addition, the shaft sheath was damaged at the instrument tip.A bent electrode could have caused this damage to the sheath.Caution should be taken not to retract the electrode into the sheath when it is bent.No conclusion could be reached as to how the tip of the electrode got bent.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.
|
|
Manufacturer Narrative
|
(b)(4).Batch # unk.The lot/batch was not provided; therefore, a manufacturing record evaluation could not be performed.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.
|
|
Event Description
|
It was reported that during an unknown procedure, there was a bent broken tip.It is unknown how procedure was completed.There was no patient consequence.
|
|
Search Alerts/Recalls
|