Catalog Number 511100150060 |
Device Problem
Material Twisted/Bent (2981)
|
Patient Problem
No Patient Involvement (2645)
|
Event Date 04/30/2020 |
Event Type
malfunction
|
Manufacturer Narrative
|
Should additional relevant information become available, a supplemental report will be submitted.
|
|
Event Description
|
It was reported the pin of a 1.5mm coupler was observed bent.This issues was identified during setup and preparation prior to patient use.There was no patient involvement.No additional information is available.
|
|
Manufacturer Narrative
|
Additional information was added to d10, h3 and h6.H10: the device was received for evaluation.Visual inspection was done to the right ring which observed two bent pins were visible.The reported condition was verified.The cause of the condition could not be determined.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.
|
|
Search Alerts/Recalls
|