MalfunctionHBI
ENDOLUMINA II TRANSILLUMINATION SYSTEM
Received Oct 16, 2001 · Event occurred Aug 29, 2001
Report 2026145-2001-00005 · MDR key 356476
Device
Generic name
Transilluminating Bougie Cable
Manufacturer
Bioenterics CorporationModel number
56 FRENCHCatalog number
E 5630
Lot number
NI
Product problems
- Detachment Of Device Component
Patient
NO INFO
- Surgical procedure
- Foreign body, removal of
Narrative
Description of Event or Problem
IT WAS REPORTED BY THE INITIAL REPORTER THAT WHEN THE SURGEON REMOVED THE TRANSILLUMINATING CABLE FROM THE PATIENT THE DEVICE'S TIP BECAME DETACHED. ENDOSCOPY WAS PERFORMED TO RETRIEVE THE TIP. THE PT WAS NOT INJURED. THERE WAS NO DETERIORATION OF THE PATIENT'S HEALTH REPORTED IN ASSOCIATION WITH THIS INCIDENT.
Remedial action
- Other