Model Number 550 |
Device Problem
Material Integrity Problem (2978)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 04/23/2019 |
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.(b)(4).
|
|
Event Description
|
A surgeon reported that after the completion of the cases for the day, she felt that her 120 micron flaps were becoming thinner as the day went on.Additional information requested.
|
|
Manufacturer Narrative
|
The manufacturing device history record (dhr) was reviewed.Based on assessment, the product met specifications at the time of release.The root cause cannot be determined conclusively.The manufacturer internal reference number is: (b)(4).
|
|
Search Alerts/Recalls
|