Catalog Number 4150030 |
Device Problem
Optical Obstruction (3002)
|
Patient Problem
No Patient Involvement (2645)
|
Event Date 10/10/2019 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).
|
|
Event Description
|
Complaint alleges the light pipe was blocked by tongue tissue during a tracheal intubation on a cadaver.It was reported the tongue tissue folded over in front of the light pipe causing darkness in the throat.
|
|
Event Description
|
Complaint alleges the light pipe was blocked by tongue tissue during a tracheal intubation on a cadaver.It was reported the tongue tissue folded over in front of the light pipe causing darkness in the throat.
|
|
Manufacturer Narrative
|
Qn#(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.While the complaint cannot be confirmed without a physical sample, historical complaint data was reviewed and several occurrences of similar complaints (light blockage with polaris blades) were identified.The previous complaints have resulted in the initiation of a capa to address a customer preference issue related to the functional use of the polaris blades.Teleflex will continue to monitor and trend for reports of this nature.
|
|
Search Alerts/Recalls
|