Device product
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
Z-1852-2012
Product summary
- Event
- Event 61935
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1340 units
- Official record key
device-enforcement:Z-1852-2012
Official wording
Reason: Difficulty in extending snare loop from the catheter
Code information: Lot Number: 14974048
Distribution pattern: Worldwide Distribution - USA (nationwide) and the countries of Canada, Australia, Austria, Belgium, France, GB, Germany, Italy, Netherlands, Qatar, Spain, Sweden, and Switzerland
Derived failure modes
-
Unknown
Difficulty in extending snare loop from the catheter