Z-0453-2013 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- December 12, 2012
- Initiation Date
- November 5, 2012
- Termination Date
- October 16, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 45 units
Product Description
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
Reason for Recall
Failure of glue joint, allowed a portion of the single use device to shift inside, may separate and fall into the patient
Distribution Pattern
Nationwide Distribution including AZ, FL, MA, NY, OH, and OR.
Code Information
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 :