Device product
EVac 70 XTRA with Integrated Cable and PROcise EZ View with Integrated Cable Product Usage: PLASMA WAND devices are indicated for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery including: adenoidectomy, cysts, head, neck, oral, and sinus surgery, mastoidectomy, myringotomy with effective hemorrhage control, nasal airway obstruction be reduction of hypertrophic nasal turbinates, nasopharyngeal/laryngeal indications including tracheal procedures, laryngeal polypectomy, and laryngeal lesion debulking, neck mass, papilloma keloids, submucosal palatal shrinkage, submucosal tissue shrinkage, tonsillectomy (including palatine tonsils), traditional uvulopalatoplasty (RAUP), tumors, and tissue in the uvula/soft palate for the treatment of snoring. It is intended for procedures using a conductive media, such as normal saline or Ringers lactate.
Z-2105-2015
Product summary
- Event
- Event 71468
- Status
- Terminated
- Classification
- Class II
- Quantity
- 733 devices
- Official record key
device-enforcement:Z-2105-2015
Official wording
Reason: Wands inspected with the adaptor fixture were released to the field not meeting the dielectric (Hipot) specifications.
Code information: Lot numbers 1093290 and 1091254
Distribution pattern: Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Germany, Spain, United Kingdom, Ireland, India, Italy and Singapore.
Derived failure modes
-
Unknown
Wands inspected with the adaptor fixture were released to the field not meeting the dielectric (Hipot) specifications.