InjuryFDX

INFINIRTY ERCP SAMPLING DEVICE

Received Jun 7, 2024

Report MW5155992 · MDR key 19499110

Device

Generic name

Endoscopic Cytology Brush

Manufacturer

Steris/ United State Endoscopy Group, Inc.

Lot number

6939885

Patient

49 YR · Male

Device Embedded In Tissue or Plaque
Device Embedded In Tissue or Plaque

Narrative

Description of Event or Problem

DURING ERCP EGDE UPPER ENDOSCOPIC ULTRASOUND PROCEDURE THE MARKER ON THE SAMPLING DEVICE SHEATH BROKE OFF. DOCTOR WAS UNSUCCESSFUL IN RETRIEVING. THREE STERIS SAMPLING DEVICES WAS USED (TWO LOT NUMBERS WERE THE SAME AND THE THIRD ONE IS DIFFERENT) PATIENT TO UNDERGO ANOTHER PROCEDURE TOMORROW LONGER WITH STENT IN ORDER TO RETRIEVE.