InjuryEEA
EEA
Received May 25, 2016 · Event occurred Feb 1, 2016
Report MW5062465 · MDR key 5678957
Device
Manufacturer
CovidienProduct problems
- Inadequacy of Device Shape and/or Size
Patient
49.000 YR
- Hemorrhage/Blood Loss/Bleeding
- Injury
- Hemorrhage/Blood Loss/Bleeding
- Injury
Narrative
Description of Event or Problem
(B)(4). DURING ATTEMPTED PLACEMENT OF THIS DEVICE PERORAL, IT BECAME STUCK AND REQUIRED 30-45 MINUTES TO PASS INSTEAD OF 3 MINUTES AS EXPECTED. SIGNIFICANT MUCOSAL DAMAGE AND BLEEDING OCCURRED. IT APPEARED THAT THE DEVICE WAS NOT THE RIGHT SHAPE AND WAS TOO BIG.