MalfunctionNNL
10 MM ENDOCATCH BAG
Received Oct 18, 2021 · Event occurred Oct 4, 2021
Report MW5104722 · MDR key 12660129
Device
Generic name
Container, Specimen Mailer And Storage, Temperature Controlled, Sterile
Manufacturer
CovidienModel number
6252103076Lot number
FEP93611B
Product problems
- Activation Failure
Patient
17 YR
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
ENDO-CATCH BAG DID NOT DEPLOY PROPERLY DURING LAPAROSCOPIC PROCEDURE, KNOT WITHIN BAG. PHYSICIAN ABLE TO EXTRACT BAG INTACT WITH SPECIMEN. FDA SAFETY REPORT ID# (B)(4).