Device product
EEA Circular Stapler with Tri-Staple Technology, Part No. TRIEEA28MT TRIEEA28XT TRIEEA31MT TRIEEA31XT Product Usage: The EEA Circular Stapler with Tri-Staple Technology places a circular, triple staggered row of titanium staples and resects the excess tissue, creating a circular anastomosis.
Z-0070-2019
Product summary
- Firm
- COVIDIEN LLC
- Event
- Event 81043
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,902
- Official record key
device-enforcement:Z-0070-2019
Official wording
Reason: The firm identified the potential for a device to have an incorrect tissue gap. Use of a device with an incorrect tissue gap may result in incomplete staple formation and/or the inability to remove the device from tissue following application potentially leading to bleeding, anastomotic leak or tissue trauma. There have been no reports of serious injury related to this issue.
Code information: P8A0976X P8A0977X P8A0978X P8A0979X P8A0980X P8A0981X P8B1538X P8B1539X P8B1540X P8B1541X P8B1542X P8C0032X P8C0033X P8C1177X P8C1178X P8C1179X P8C1180X P8C1181X P8C1183X P8D1405X P8D1406X P8D1407X P8D1408X P8D1409X P8D1410X P8D1411X P8E1211X P8E1212X P8E1213X P8E1214X P8E1215X P8E1216X P8E1217X P8E1304X P8E1305X
Distribution pattern: Worldwide Distribution - US Nationwide in the states of CA, FL, IL, NC, NY, UT. and the countries of Austria, Belgium, Denmark, Finland, France, Germany, Iceland, Italy, Latvia, Netherlands, Norway, Poland, Portugal, Reunion, Spain, Sweden, Switzerland, and United Kingdom.
Derived failure modes
-
Unknown
The firm identified the potential for a device to have an incorrect tissue gap. Use of a device with an incorrect tissue gap may result in incomplete staple formation and/or the inability to remove the device from tissue following application potentially leading to bleeding, anastomotic leak or tissue trauma. There have been no reports of serious injury related to this issue.