inforMED
MalfunctionKDW

COVIDIEN ENDO CATCH II

Received Jul 29, 2020 · Event occurred Jul 15, 2020

Report MW5095794 · MDR key 10343712

Device

Generic name

Container, Specimen Mailer And Storage, Temperature Controlled, Sterile

Manufacturer

Covidien

Model number

173049

Lot number

J0E1669HY

Product problems

  • Break

Patient

Not reported

  • No Known Impact Or Consequence To Patient
  • No Known Impact Or Consequence To Patient

Narrative

Description of Event or Problem

ENDO CATCH 11 SPECIMEN RETRIEVAL POUCH WAS BEING USED BY PHYSICIAN TO EXTRACT SPECIMEN FROM ABDOMEN AND THE BOTTOM OF POUCH BROKE AT THE SEAM. FDA SAFETY REPORT ID# (B)(4).