|
Model Number CA500 |
Device Problem
Failure to Fire (2610)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Type
malfunction
|
Event Description
|
Procedure performed: unknown event description: (b)(4).Customer had several complains before.They totally lost trust and don't want to use the clipper anymore.Since month very often problems, the clipper is just not functional.Information received by applied medical rep via email on 28feb24: no clips made it between the branches.The customer hasn't submitted all complaints, because customers are upset and tired to do that again and again.Information received by applied medical rep via email on 29feb24: there are a lot of complaint not reported, and also never afterwards.Information received by applied medical rep via email on 11mar24: no patient injury happened, there are about 20 not reported cases and all cases regarding to no clip loaded issue.Patient status: no impact to patient intervention: unknown.
|
|
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 is unknown, however, it is likely to be within the scope of the recall.
|
|
Search Alerts/Recalls
|
|
|