Catalog Number ASKU |
Device Problem
Leak/Splash (1354)
|
Patient Problem
Complaint, Ill-Defined (2331)
|
Event Date 12/08/2016 |
Event Type
malfunction
|
Manufacturer Narrative
|
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
|
|
Event Description
|
An ophthalmic surgeon reported that during the vitreo-retinal procedures, the valved trocars leaked immediately after "insertion and removal of the trocar" so he either gets "plugs ready" or "else put up with the leaks".No product sample was kept.There was harm to the patients.No additional information is expected.This is two for two reports for the same event date.
|
|
Manufacturer Narrative
|
Supplemental medical device report (smdr) # 01 is being filed as the date received by manufacturer date provided in the initial medical device report was incorrect.The correct date received by manufacturer date was 12/08/2016.The incorrect date received by manufacturer date was 02/08/2016.(b)(4).
|
|
Manufacturer Narrative
|
No sample has been returned for evaluation; therefore, the condition of the product could not be verified.No lot number was identified with this complaint; therefore, lot history and complaint history reviews could not be conducted.Due to an observed increased trend for this event, an internal investigation was initiated to determine if corrective and preventative actions were necessary.A root cause for the increased complaint rate was found to be related to a manufacturing post assembly inspection practice.This complaint does not identify a reported lot and no sample was returned for evaluation so it cannot be determined if the complaint can be attributed to the post assembly inspection.The post assembly inspection has been discontinued and an effectiveness check has been established and will be monitored periodically.(b)(4).
|
|
Search Alerts/Recalls
|