Worldwide Distribution - USA (nationwide) and the countries of Canada, Australia, Austria, Belgium, France, GB, Germany, Italy, Netherlands, Qatar, Spain, Sweden, and Switzerland
Description du dispositif
Boston Scientific Profile Single-Use Pediatric Snare 11mm || UPN Outer Box M00562531 || Inner Pouch: M00562530 , || The single-use Profile Polypectomy Snare consists of a flexible wire cable loop which can be extended and retracted from the snare's flexible outer sheath using a three-ring handle. When passed through an endoscope and activated, the snare delivers a monopolar electrical current to cut and cauterize tissue with the loop
“We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
Worldwide Distribution - USA (nationwide) and the countries of Canada, Australia, Austria, Belgium, France, GB, Germany, Italy, Netherlands, Qatar, Spain, Sweden, and Switzerland
Description du dispositif
Boston Scientific Profile Single-Use Pediatric Snare 13mm || UPN Outer Box: M00562551 || Inner Pouch: M00562550 || The single-use Profile Polypectomy Snare consists of a flexible wire cable loop which can be extended and retracted from the snare's flexible outer sheath using a three-ring handle. When passed through an endoscope and activated, the snare delivers a monopolar electrical current to cut and cauterize tissue with the loop
Worldwide Distribution - USA (nationwide) and the countries of Canada, Australia, Austria, Belgium, France, GB, Germany, Italy, Netherlands, Qatar, Spain, Sweden, and Switzerland
Description du dispositif
Boston Scientific Profile Single-Use Pediatric Snare 27mm || UPN Outer Box: M00562571 || Inner Pouch: M00562570 || The single-use Profile Polypectomy Snare consists of a flexible wire cable loop which can be extended and retracted from the snare's flexible outer sheath using a three-ring handle. When passed through an endoscope and activated, the snare delivers a monopolar electrical current to cut and cauterize tissue with the loop