Catalog Number 544965 |
Device Problem
Activation, Positioning or Separation Problem (2906)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 06/22/2020 |
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 the jaws of the applier did not open enough to load a clip properly during a surgery.Therefore, a new unit was used instead.It was the first use of the applier after purchasing it on (b)(6) 2020.
|
|
Event Description
|
It was reported that the jaws of the applier did not open enough to load a clip properly during a surgery.Therefore, a new unit was used instead.It was the first use of the applier after purchasing it on may 2020.
|
|
Manufacturer Narrative
|
(b)(4).Per customer provided information the dhr for the alleged instrument was reviewed and found completely without any irregularities.The alleged instrument was produced at the tecomet, inc.Kenosha wi facility as part of a 50 pc.Lot in august of 2019.This instrument has not been returned for review or evaluation therefore we are unable to determine what may have caused the alleged defect or validate the alleged complaint.All 50 instruments from the alleged lot were 100% visually inspected and function tested prior to shipment to the customer as this is a standardized procedure at this facility for the product line.
|
|
Search Alerts/Recalls
|