OMNICLOSE TROCAR SITE CLOSURE NEEDLE
Received Nov 3, 2017 · Event occurred Sep 13, 2017
Report 3007791595-2017-00012 · MDR key 6998588
Device
Generic name
Trocar Site Closure
Manufacturer
Unimax Medical Systems IncModel number
FCL201100Catalog number
FCL201100
Lot number
8101705035
Product problems
- Device Operates Differently Than Expected
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
THE DHR FOR THE PRODUCT IN QUESTION WAS REVIEWED AND FOUND WITHOUT ANY IRREGULARITIES. IT IS UNCLEAR UNDER WHAT CIRCUMSTANCES COULD THE DEVICE CUT THE SUTURE CONSIDERING THE STRUCTURE AND OPERATION PRINCIPLE OF THE DEVICE. THE STRUCTURE OF THE GRASPING JAWS ARE ROUNDED WITHOUT SHARP EDGES. THE OPERATION PRINCIPLE IS TO GRASP THE SUTURE AND HOLD IT IN THE LOOP CREATED BY THE JAWS INSTEAD OF FIRMLY CLIPPING IT. A REVIEW OF THE RECORD INDICATES THAT THERE IS NO SIMILAR ISSUE SINCE THE PRODUCT IS LAUNCHED. THE EVENT WILL BE CLOSED. IF THE ADDITIONAL INFORMATION COULD BE OBTAINED FOR FURTHER INVESTIGATION, THE SUPPLEMENTAL REPORT WILL BE FILED.
Description of Event or Problem
WHEN THE GRASPERS WERE CLOSED AND PULLING THE SUTURE IN, IT CUT THROUGH THE SUTURE INSTEAD OF GRASPING IT.