inforMED
InjuryFCH

ENDOCHOICE

Received Feb 15, 2018 · Event occurred Jan 16, 2018

Report MW5075303 · MDR key 7276141

Device

Generic name

Tray, Biopsy, Without Biopsy Instruments

Model number

205644

Catalog number

0100840253113337

Lot number

205644

Product problems

  • Break

Patient

78 YR

  • No Known Impact Or Consequence To Patient
  • No Known Impact Or Consequence To Patient

Narrative

Description of Event or Problem

ENDOCHOISE COMPLIANCE ENDOKIT HEDGEHOG DUAL END BRUSH REF CEK-721-20 LOT 205644 EXP 08/2019. BRUSH END BROKE OFF AND REMAINED LODGED IN ENDOSCOPE.