SPYBITE MAX
Received Jun 2, 2026 · Event occurred May 11, 2026
Report 3005099803-2026-02275 · MDR key 25368501
Device
Generic name
Forceps, Biopsy, Non-electric
Manufacturer
Boston Scientific CorporationModel number
M00546470Catalog number
M00546470
Lot number
0038439164
Product problems
- Difficult to Advance
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
BLOCK H6: IMDRF F1001 CAPTURES THE REPORTABLE EVENT OF ABORTED PROCEDURE.
Description of Event or Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYBITE MAX BIOPSY FORCEPS WAS USED IN THE DISTAL COMMON BILE DUCT FOR BIOPSY DURING A CHOLANGIOSCOPY PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, IT WAS REPORTED THAT THE FORCEPS COULD NOT BE INSERTED THROUGH THE SCOPE. AS A RESULT, THE PROCEDURE WAS NOT COMPLETED WITH THE PATIENT UNDER SEDATION. THE PATIENT WAS NOT YET RESCHEDULED FOR ANOTHER PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.