Catalog Number 544965 |
Device Problems
Break (1069); Activation, Positioning or Separation Problem (2906)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 08/03/2020 |
Event Type
malfunction
|
Manufacturer Narrative
|
Qn#: (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 flush port got detached during use.Also, the user felt that the shaft did not rotate smoothly and the jaws did not open/close smoothly.Therefore, a new unit was used instead.The applier was purchased by the hospital in july and used twice.
|
|
Event Description
|
It was reported that the flush port got detached during use.Also, the user felt that the shaft did not rotate smoothly and the jaws did not open/close smoothly.Therefore, a new unit was used instead.The applier was purchased by the hospital in july and used twice.
|
|
Manufacturer Narrative
|
Qn#(b)(4).The dhr for the returned instrument was reviewed and found completely without any irregularities.This instrument was produced at the tecomet , inc.Kenosha wi facility as part of a (b)(4) pc.Lot in november of 2019.Evaluation of the returned instrument shows that the flush port, seal and cap are not installed in the knob assembly and are separated from the knob assembly in the bag as returned therefore we are able to validate this complaint.Further evaluation after the outer tube assembly was aligned with the drive rod coupling and the flush port and seal were re-installed shows that this instrument is now able to pick- p, retain, close and release multiple clips both with and without the use of silastic test tubing.We are unable to determine how the flush port came loose from the knob assembly but mishandling of this device at the end user's location is suspected.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
|