Model Number VH-4000 |
Device Problem
Mechanical Problem (1384)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 12/19/2023 |
Event Type
malfunction
|
Event Description
|
The hospital reported that during an endoscopic vein harvesting procedure, vasoview hemopro 2 takes multiple tries to use the trigger to burn with cautery.Procedure was completed with the same device.Procedural delay in making/trying to make the device transfer energy.No patient harm or effects.
|
|
Manufacturer Narrative
|
Tw id (b)(4).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.H3 other text : device discarded.
|
|
Manufacturer Narrative
|
Trackwise#: (b)(4).The lot # 3000351643 history record review was completed.There were no ncmrs, rework, or deviations documented for the reported lot number.Based on the dhr/lhr review results, it was determined that there is no relation between the batch manufacturing process and the reported failure.
|
|
Event Description
|
N/a.
|
|
Search Alerts/Recalls
|