Device product
PolypVac 3.5mm Microdebrider; Catalog Number FG-000016; contents: 1 Microdebrider, 1 Stylet, 1 filter. Sterile. Used for the excision of polyps in the nasal passageways and in sinuses for which access has been previously established.
Z-1527-2014
Product summary
- Firm
- Laurimed LLC
- Event
- Event 67950
- Status
- Terminated
- Classification
- Class III
- Quantity
- 58
- Official record key
device-enforcement:Z-1527-2014
Official wording
Reason: The reciprocation mechanism in the PolypVac Microdebrider may turn off prematurely due to a component failure in the device handle.
Code information: Lot Number: LFG-111813-1; Expiry date: June 2014; LFG020614-01, Expiry date: September 2014.
Distribution pattern: Distributed in the states of CA, VT, NC, DO, TX, FL, PA, OR, AZ, IL, ID, and VA.
Derived failure modes
-
Unknown
The reciprocation mechanism in the PolypVac Microdebrider may turn off prematurely due to a component failure in the device handle.