Catalog Number C-HSK-3043 |
Device Problem
Failure to Advance (2524)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 09/26/2017 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).A lot history record review was completed for the reported product lot number.There was no nonconformance recorded in the lot history.Since the device is not available to be returned to us, a technical evaluation cannot be performed.Per our standard sop's, all events are tracked and trended to determine whether or not any trends develop.
|
|
Event Description
|
The hospital reported that during preparation for an endoscopic vein harvesting procedure, hs iii proximal seal system 4.3mm did not load properly.A replacement device was used to complete the procedure.The hospital did not report any patient effects.
|
|
Manufacturer Narrative
|
(b)(4).
|
|
Event Description
|
The hospital reported that during preparation for an endoscopic vein harvesting procedure, hs iii proximal seal system 4.3mm did not load properly.A replacement device was used to complete the procedure.There was no patient involvement.
|
|
Search Alerts/Recalls
|