|
Model Number SHEATH, 2 STOPCOCK FOR 2.7MM SCOPE |
Device Problem
Defective Device (2588)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 10/23/2023 |
Event Type
malfunction
|
Manufacturer Narrative
|
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
|
|
Event Description
|
On (b)(6) 2023, it was reported by a sales representative via sems-06064578 that an ar-3372-2702 sheath is damaged non-specifically.This was discovered during use with no patient harm.
|
|
Search Alerts/Recalls
|
|
|