BLOX
Received Jul 6, 2026 · Event occurred Jun 11, 2026
Report 3005099803-2026-02688 · MDR key 25725412
Device
Generic name
Endoscopic Bite Block
Manufacturer
Jiangsu Jianyu Health Medical Co LtdModel number
SBT-114-100Catalog number
SBT-114-100
Lot number
0000250823
Product problems
- Material Separation
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
BLOCK H6: IMDRF DEVICE CODE A0413 CAPTURES THE REPORTABLE EVENT OF BITE BLOX MATERIAL SEPARATION. BLOCK G1: (B)(6).
Description of Event or Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A BITE BLOX WAS USED FOR THE LUNGS DURING BRONCHOSCOPY PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE BITE BLOCK WAS PLACED IN THE PATIENTS MOUTH AND THE PATIENT BIT DOWN FORCEFULLY ON THE DEVICE, CAUSING IT TO BECOME DAMAGED. THE PROCEDURE WAS COMPLETED WITH A ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATION AS A RESULT OF THIS EVENT.