Device product
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
Z-0453-2013
Product summary
- Firm
- OmniGuide, Inc.
- Event
- Event 63642
- Status
- Terminated
- Classification
- Class II
- Quantity
- 45 units
- Official record key
device-enforcement:Z-0453-2013
Official wording
Reason: Failure of glue joint, allowed a portion of the single use device to shift inside, may separate and fall into the patient
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 :
Distribution pattern: Nationwide Distribution including AZ, FL, MA, NY, OH, and OR.
Derived failure modes
-
Unknown
Failure of glue joint, allowed a portion of the single use device to shift inside, may separate and fall into the patient