MalfunctionFAT
BIO ENTERICS CORP
Received Oct 9, 1998 · Event occurred Jul 17, 1998
Report MW1014741 · MDR key 192022
Device
Generic name
Endolumina Ii
Manufacturer
Bioenterics Corp.Model number
50FRCatalog number
E5031-10
Lot number
*
Product problems
- Disconnection
- Difficult to Remove
Patient
23 YR
- Therapy/non-surgical treatment, additional
Narrative
Description of Event or Problem
A LIGHTED ESOPHAGEAL BOUGIE USED INTRAOPERATIVELY. A DISPOSABLE TIP SNAPS ON & OFF DEVICE. WHEN INSERTING THE BOUGIE, THE TIP DISCONNECTED FROM THE BOUGIE, LEAVING IT IN THE ESOPHAGUS. HAD TO REMOVE IT WITH FORCEPS. EVIDENTLY THIS LIGHTED BOUGIE IS A NEW VERSION OF THE ONE STAFF HAVE USED FOR THE PAST 4 YEARS. THE ORIGINAL UNIT DOESN'T HAVE A DETACHABLE TIP; IT IS PERMANENTLY ATTACHED. ACCORDING TO THE MFR THE ORIGINAL MODEL IS BEING PHASED OUT.