Catalog Number 8065751900 |
Device Problem
Leak/Splash (1354)
|
Patient Problem
Retinal Tear (2050)
|
Event Date 01/25/2016 |
Event Type
Injury
|
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.(b)(4).
|
|
Event Description
|
A surgeon reported that "leaking occurred when the trocar valve cannula was removed." the leaking was coming from two of the cannulas.It was noted that vitreous incarceration occurred with retina tear.Additional information has been requested for this event.However, upon follow up the customer informed that the product sample associated with this event was discarded after the procedure.No other updates have been received at this time.
|
|
Manufacturer Narrative
|
No sample has been returned for evaluation; therefore, the condition of the product could not be verified.The final customer lot was identified.A device history record review for each of the component lots was conducted.According to the device history record review the product released met the product¿s acceptance criteria.The root cause for the defect experienced by the customer cannot be determined.(b)(4).
|
|
Search Alerts/Recalls
|