inforMED
MalfunctionEZP

CONVATEC LOOP OSTOMY ROD

Received Mar 17, 2005 · Event occurred Feb 17, 2005

Report 1049092-2005-00008 · MDR key 584549

Device

Generic name

Ostomy Rod

Manufacturer

Convatec

Model number

*

Catalog number

22355

Lot number

2D53535

Product problems

  • Break
  • Replace

Patient

UNKNOWN

  • No Consequences Or Impact To Patient

Narrative

Description of Event or Problem

NURSE RISK MANAGER REPORTS DURING TRANSVERSE COLOSTOMY PROCEDURE IN 2005, THE CONVATEC LOOP OSTOMY ROD BROKE INTO TWO PIECES. THE SURGEON WAS INSERTING THE LOOP AT THE TIME IT BROKE. HE WAS ABLE TO REMOVE THE PIECES WITH NO ADVERSE AFFECT TO THE PATIENT AND REPLACED IT WITH ANOTHER ROD.