inforMED
InjuryPKL

COLONIC FTRD SET

Received Jun 1, 2022 · Event occurred Feb 1, 2022

Report 3006696607-2022-00004 · MDR key 14559154

Device

Generic name

Colonic Ftrd Set

Model number

200.70

Catalog number

200.70

Lot number

825497

Product problems

  • Use of Device Problem
  • Use of Device Problem

Patient

Unknown

  • Bowel Perforation
  • Bowel Perforation

Narrative

Description of Event or Problem

A COLONIC FTRD SET (CFTRD), MANUFACTURER OVESCO ENDOSCOPY AG, WAS USED FOR AN ENDOSCOPIC FULL THICKNESS RESECTION OF A 1,8 CM SIZE LESION IN THE ASCENDING COLON. THE ENDOSCOPIC INTERVENTIONIST ASSUMED THAT THE CLIP OF THE COLONIC FTRD SET IN QUESTION HAD BEEN SUCCESSFULLY APPLIED AND, HENCE, PROCEEDED TO PERFORM THE FULL THICKNESS RESECTION. HOWEVER, CLIP APPLICATION WAS VISUALLY NOT VERIFIED BEFOREHAND. THE PERFORATION CAUSED WAS CLOSED BY SURGERY. AS REPORTED TO US THE PATIENT RECOVERED UNEVENTFULLY.

Additional Manufacturer Narrative

IN SUMMARY, THERE IS NO INDICATION OF A TECHNICAL FAILURE OF THE DEVICE. NONE OF THE DMRS SHOWED ANY DEVIATION. THE RISK OF CAUSING A PERFORATION IS INDICATED IN THE INSTRUCTION FOR USE. MOREOVER, IT IS ADDRESSED IN USER TRAININGS WE PERFORM. IT IS RECOMMENDED TO VERIFY A SUCCESSFUL CLIP APPLICATION BEFORE RESECTING THE TARGET TISSUE. IN CONCLUSION, THE DETERMINED ROOT CAUSE IS A PROCEDURAL COMPLICATION, NOT A TECHNICAL FAILURE.