BLOX
Received May 13, 2026 · Event occurred Mar 3, 2026
Report 3005099803-2026-01882 · MDR key 25166441
Device
Generic name
Endoscopic Bite Block
Manufacturer
Jiangsu Jianyu Health Medical Co LtdModel number
SBT-321-100Catalog number
SBT-321-100
Lot number
0000250801
Product problems
- Material Separation
Patient
NA · Male
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A BITE BLOX WAS USED IN THE MOUTH DURING A BRONCHOSCOPY PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, A LOUD POPPING SOUND WAS HEARD. IT WAS DISCOVERED THAT THE PATIENT HAD BITTEN DOWN ON THE BITE BLOX, CAUSING A PIECE OF THE BITE BLOX TO BREAK OFF. THE PATIENT REQUIRED FURTHER EVALUATION USING A SECOND BRONCHOSCOPE TO CONFIRM THAT NO FRAGMENT HAD ENTERED THE AIRWAY OR LUNGS. THERE WERE NO PATIENT COMPLICATION AS A RESULT OF THIS EVENT.
Additional Manufacturer Narrative
BLOCK H6: IMDRF DEVICE CODE A0413 CAPTURES THE REPORTABLE EVENT OF BITE BLOX MATERIAL SEPARATION.