inforMED
MalfunctionGBX

TOTAL ABSCESSION

Received Mar 10, 2017 · Event occurred Dec 9, 2016

Report 6394698 · MDR key 6394698

Device

Generic name

Catheter, Irrigation

Model number

14000802

Catalog number

14000802

Lot number

5080321

Product problems

  • Detachment Of Device Component

Patient

59 YR

  • Foreign Body In Patient
  • Foreign Body In Patient

Narrative

Description of Event or Problem

DURING A ROUTINE UROLOGIC PROCEDURE A TINY PIECE OF THE TIP OF A TOTAL ABSCESSION CATHETER WAS NOTED TO BE ENCAPSULATED IN A LYMPHOCELE. THE FOREIGN BODY WAS REMOVED DURING THE ROUTINE PROCEDURE. THE PATIENT WAS NOT HARMED, NO SIGNS OF INFECTION WERE PRESENT.

Additional Manufacturer Narrative

UNIQUE DEVICE IDENTIFIER (UDI): FOR TYPE OF DEVICE: CATHETER, IRRIGATION.

Description of Event or Problem

DURING A ROUTINE UROLOGIC PROCEDURE A TINY PIECE OF THE TIP OF A TOTAL ABSCESSION CATHETER WAS NOTED TO BE ENCAPSULATED IN A LYMPHOCELE. THE FOREIGN BODY WAS REMOVED DURING THE ROUTINE PROCEDURE. THE PATIENT WAS NOT HARMED, NO SIGNS OF INFECTION WERE PRESENT.