|
Model Number CA500 |
Device Problem
Failure to Fire (2610)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Type
malfunction
|
Manufacturer Narrative
|
Applied medical has issued a voluntary recall of our epix universal clip applier for specific ca500 lots.These ca500 units are being recalled due to a nonconformance that may result in a clip not loading into the jaws after the trigger is actuated.Applied medical has recently implemented manufacturing corrections which are intended to reduce the potential for this type of incident to reoccur.The lot associated with this complaint, #(b)(4), was included in the recall.
|
|
Event Description
|
Procedure performed: ni.Event description: [hospital]."after clips were loaded, it failed to be fired.The clips were loaded and fired first, but it failed to fire clips since the middle of the procedure." product is available for return.Additional information was received via email on 02feb2024 from [name], amk territory manager."it is unknown what trocar was used.A clip properly seated into the jaws.Any pressure was not applied to the trigger while moving through the trocar.A clip was not loaded into the jaws prior to the device's insetion/removal through the trocar.A clip was not manually removed as a loaded clip, leaving the feeder exposed." patient status: there was no problem with the patient.Intervention: the case was completed with the new device.
|
|
Search Alerts/Recalls
|
|
|