Compliance EndoKit
Received Jul 7, 2026 · Event occurred Jun 19, 2026
Report 3005099803-2026-02705 · MDR key 25740355
Device
Generic name
Accessories, Cleaning Brushes, For Endoscope
Manufacturer
Boston Scientific CorporationModel number
CEK-746-20Catalog number
CEK-746-20
Product problems
- Device Contamination with Chemical or Other Material
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
BLOCK B3 (DATE OF EVENT): DATE OF EVENT WAS APPROXIMATED TO 06/01/2026 AS NO EVENT DATE WAS REPORTED. BLOCK D4, H4: THE COMPLAINANT WAS UNABLE TO REPORT THE LOT NUMBER; THEREFORE THE MANUFACTURE DATE AND EXPIRATION DATE ARE UNKNOWN. BLOCK H6: IMDRF DEVICE CODE A180104 CAPTURES THE REPORTABLE EVENT OF DEVICE CONTAMINATION WITH CHEMICAL OR OTHER MATERIAL.
Description of Event or Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A COMPLIANCE ENDOKIT WAS BEING UNPACKED ON AN UNKNOWN DATE. UPON OPENING THE PRODUCT, A LIVE INSECT WAS FOUND INSIDE THE PACKAGING; THEREFORE, THE PRODUCT COULD NOT BE USED. THERE WAS NO PATIENT INVOLVEMENT IN THIS EVENT.