Catalog Number AE05ML |
Device Problems
Leak/Splash (1354); Misfire (2532); Device Fell (4014)
|
Patient Problem
No Information (3190)
|
Event Date 08/20/2019 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
|
|
Event Description
|
It was reported that clips misfired or clips not aligning.Clips fall out.
|
|
Event Description
|
It was reported that clips misfired or clips not aligning.Clips fall out.
|
|
Manufacturer Narrative
|
Qn# (b)(4).Per dhr the product auto endo5 ml lot # 73f1800409 was manufactured on 06/18/2018 a total of (b)(4) pieces.Lot was released on 06/21/2018.Dhr investigation did not show issues related to complaint.Revision of fmea-08-029 rev 04 was performed and the failure mode is already including it, no update is required.Corrective actions cannot be established since it is necessary to receive the physical sample to perform a proper investigation and confirm the alleged defect.At this time due the sample is not available is not possible to determine the source of the defect reported.Customer complaint cannot be confirmed due the product sample is not available to perform a proper investigation and determinate the root cause.If the alleged defect samples become available at a later date, this complaint will be updated accordingly.
|
|
Manufacturer Narrative
|
(b)(4) after an additional medical review, a determination was made to re-classify the complaint as a malfunction.Complaint (b)(4) is being reported as a malfunction.There was no serious injury.
|
|
Search Alerts/Recalls
|