Device product
Tube Set for TEM - Product Usage: Transanal Endoscopic Microsurgery (TEM) combination system and the instrument set for the TEM procedure are designed to provide access to the rectal cavity and accessible part of the lower sigmoid colon using a stereo and/or monocular endoscope under gas tight conditions for the excision of polyps and/or the removal of tumors that have been previously staged.
Z-2706-2020
Product summary
- Event
- Event 85863
- Status
- Terminated
- Classification
- Class II
- Quantity
- 338 sets
- Official record key
device-enforcement:Z-2706-2020
Official wording
Reason: Tube material of a smaller diameter was used.
Code information: Lot Number 32324159, Model # 4170.801
Distribution pattern: International distribution in the countries of Austria (AT), Canada (CA), Germany (DE), Denmark (DK), Spain (ES), France (FR), United Kingdom (GB), Hong Kong (HK), Iceland (IS), Lithuania (LT), Norway (NO), New Zealand (NZ), Sweden (SE), and Netherlands (NL).
Derived failure modes
-
Unknown
Tube material of a smaller diameter was used.