Device product
Beacon EUS Access System Preloaded Access 135degree Needle sterile, single-use, endoscopic ultrasound device consisting of a sharp stylet and an 18.5-gauge, echo-enhanced, tip-shaped, nitinol cannula intended to pierce tissue and then act as an access channel to facilitate guidewire placement to locations of the gastrointestinal tract.
Z-2769-2020
Product summary
- Firm
- Covidien Llc
- Event
- Event 86001
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 269 units
- Official record key
device-enforcement:Z-2769-2020
Official wording
Reason: This voluntary recall is being conducted following three customer reports of the device cannula detaching during a procedure. In one case, the detached cannula was not retrieved during the procedure. Potential risks associated with a detached cannula include delay in treatment, biliary leak, pain and retained device fragments.
Code information: Model # DSA-135-01 UDI: 10884521663527 Lot #: F2510371X, F2510861X, F2512341X, F2512383X, F2512493X, F2513453X
Distribution pattern: world wide distribution
Derived failure modes
-
Unknown
This voluntary recall is being conducted following three customer reports of the device cannula detaching during a procedure. In one case, the detached cannula was not retrieved during the procedure. Potential risks associated with a detached cannula include delay in treatment, biliary leak, pain and retained device fragments.