inforMED
MalfunctionLIO

ETHICON ENDO BAG

Received Feb 22, 1999 · Event occurred Feb 10, 1999

Report MW1015747 · MDR key 211106

Device

Generic name

Specimen Retrieval Bag

Model number

*

Catalog number

*

Lot number

*

Product problems

  • Component(s), broken

Patient

52 YR

  • Foreign body, removal of

Narrative

Description of Event or Problem

DURING A PELVISCOPIC PROCEDURE, AN ETHICON SPECIMEN RETRIEVAL BAG WAS USED AND REMOVED. THE MD NEEDED TO OPEN PT DUE TO DIAGNOSIS AND UPON FURTHER EXPLORATION, THE MD FOUND A METALLIC STRIP; REMOVED THE STRIP; AND IDENTIFIED THE STRIP AS PART OF THE SPECIMEN RETRIEVAL BAG. AT THE TIME THE BAG WAS REMOVED, IT WAS NOT REALIZED THAT THE SPRING HAD BROKEN OFF.