RX LOCKING DEVICE AND BIOPSY CAP
Received Apr 3, 2026 · Event occurred Mar 1, 2026
Report 3005099803-2026-01211 · MDR key 24779036
Device
Generic name
Endoscope Channel Accessory
Manufacturer
Boston Scientific CorporationModel number
M00545261Catalog number
M00545261
Lot number
0036686422
Product problems
- Detachment of Device or Device Component
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN RX LOCKING DEVICE AND BIOPSY CAP WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE SPONGE WITHIN THE BIOPSY CAP DETACHED AND WAS LODGED IN THE SCOPE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT AFTER THIS EVENT.
Additional Manufacturer Narrative
BLOCK B3: THE EXACT DATE OF THE EVENT IS UNKNOWN. THE PROVIDED EVENT DATE WAS CHOSEN AS A BEST ESTIMATE BASED ON THE DATE THAT THE MANUFACTURER BECAME AWARE OF THE EVENT. BLOCK H6: IMDRF DEVICE CODE A0501 CAPTURES THE REPORTABLE EVENT OF THE SPONGE DETACHED.