Device product
GelPOINT Path Transanal Procedural Pack with Epix Electrosurgical L-Hook with Smoke Evacuation, 4x5.5cm and 5mm x 42cm REF TA211 Product Usage: The GelPOINT Path Transanal Access Platform is indicated for multiple instrument or camera access through the anus to perform various diagnostic and/or therapeutic procedures by using additional instruments.
Z-0510-2020
Product summary
- Event
- Event 83909
- Status
- Terminated
- Classification
- Class II
- Quantity
- 39 units Domestically and 112 units Internationally
- Official record key
device-enforcement:Z-0510-2020
Official wording
Reason: Unintentional shifting of the tip insulation of the firm's electrosurgical probes.
Code information: Model Number: TA211 Lot Numbers: 1342169 and 1340118
Distribution pattern: Worldwide distribution - US Nationwide distribution and countries of Belgium; Germany; Switzerland; Spain; Finland; France; Great Britain; Israel; India; Italy; Lebanon; Netherlands; and Portugal.
Derived failure modes
-
Unknown
Unintentional shifting of the tip insulation of the firm's electrosurgical probes.