Recall Z-0453-2013— OmniGuide, Inc.

Name: FDA recall Z-0453-2013
Creator: U.S. Food and Drug Administration
Published: 2012-11-05

Class II · Terminated

Class II FDA medical device recall by OmniGuide, Inc., initiated 2012-11-05, terminated 2014-10-16. It names one FDA 510(k) clearance: K070157. 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. Reason: Failure of glue joint, allowed a portion of the single use device to shift inside, may separate and fall into the patient.

Recalling firm: OmniGuide, Inc.
Classification: Class II
Status: Terminated
Initiated: 2012-11-05
Terminated: 2014-10-16
Firm location: Cambridge, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K070157 — OMNIGUIDE BEAM PATH CO2 MARK III WAVEGUIDE FIBEROmniguide, Inc.·cleared 2007-02-01

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.