FDAFDA · Alimentos y medicamentos·N.º oficial Z-0453-2013
OmniGuide BP-ROBOTIC ( BeamPath Robotic), Single Use Cat. # BP-ROBOTIC The OmniGuide Fiber is indicated for the incision, excision, ablation, vaporization and coagulation of body soft tissues including intra-oral tissues. It is indicated in the medical specialties of general and plastic surgery, oral/maxillofacial surgery, dentistry, dermatology, gynecology, otorhinolaryngology, gastroenterology, neurosurgery, urology, and pulmonology, and can be used in open surgical procedures as well as endoscopic minimally invasive procedures in conjunction with rigid or flexible endoscopes, such as in laryngoscopy, gastroscopy, colonoscopy, laparoscopy, thoracoscopy, hysteroscopy and bronchoscopy
Publicado el 12 de diciembre de 2012 · Inicio del retiro: 5 de noviembre de 2012
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
Failure of glue joint, allowed a portion of the single use device to shift inside, may separate and fall into the patient
Qué hacer
Voluntary: Firm initiated · E-Mail
Detalles del retiro
- Fabricante
- OmniGuide, Inc.
- Distribuidor
- Nationwide Distribution including AZ, FL, MA, NY, OH, and OR.
- Lote
- Lot Numbers: LA121003AO-P1 LA121003AQ-P1 LA121001CB-P1 LA121003AL-P1 LA121002AC-P1 LA121001CC-P1 LA121001BZ-P1 LA121001BZ-P1 LA121001AR-P1 LA121001AQ-P1 LA121001CA-P1 LA120926BA-P1 LA120926AS-P1 LA120919BG-P1 LA120920AF-P1 LA120924AG-P1 :
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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