inforMED
MalfunctionOCZ

DIAGNOSTIC FTRD SET

Received Apr 12, 2023 · Event occurred Apr 3, 2023

Report 16723595 · MDR key 16723595

Device

Generic name

Endoscopic Grasping/cutting Instrument, Non-powered

Lot number

828491

Product problems

  • Adverse Event Without Identified Device or Use Problem

Patient

20440 DA · Female

  • Granuloma
  • Granuloma

Narrative

Description of Event or Problem

THE DOCTOR WAS PERFORMING COLONOSCOPY W/ FULL-THICKNESS RESECTION AND INTENDED TO USE OVESCO FTRD DEVICE. THE PRIOR POLYPECTOMY SITE WAS NOTED IN ASCENDING COLON. AT BOTH ENDS OF THE SCAR TISSUE, GRANULATION NODULES WERE NOTED. IN THE MIDDLE OF THE SCAR TISSUE, VERY SMALL POLYPOID TISSUE WAS NOTED. THE SITE WAS MARKED BY COAG AND SCOPE WAS WITHDRAWN AND FTRD DEVICE MOUNTED. THEN, THE SCOPE WAS REINSERTED, AND THE MARKED SITE WAS GRABBED WITH LARGE FORCEPS DEVICE INTO THE FTRD CHANNEL. CLIP COULD NOT BE RELEASED (DID NOT DEPLOY), SO PROCEDURE WAS ENDED. NO RESECTION OF POLYP. THE FTRD DEVICE WAS REMOVED FROM SCOPE AND THE SITE WAS REINSPECTED.