inforMED
MalfunctionFAT

INFRAVISION 56 FR. ESOPHAGEAL KIT (5BX)

Received Jul 17, 2008 · Event occurred Jun 24, 2008

Report 2936485-2008-00061 · MDR key 1078964

Device

Generic name

E-kit

Catalog number

0220180540

Lot number

UNKNOWN

Product problems

  • Material Separation
  • Device, removal of (non-implant)

Patient

UNK

  • Foreign body, removal of

Narrative

Description of Event or Problem

IT WAS REPORTED THAT TUBING FELL APART IN PATIENT'S THROAT. ALL OF IT WAS RETRIEVED AND PROCEDURE WAS COMPLETED SUCCESSFULLY.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION WILL BE PROVIDED ONCE INVESTIGATION IS COMPLETED.

Remedial action

  • Recall