inforMED
InjuryPKL

COLONIC FTRD SET

Received Oct 12, 2022 · Event occurred Aug 17, 2022

Report 3006696607-2022-00006 · MDR key 15586339

Device

Generic name

Colonic Ftrd Set

Model number

200.70

Catalog number

200.70

Lot number

837366

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 (B)(4), WAS USED FOR AN ENDOSCOPIC FULL THICKNESS RESECTION OF A 1.5 CM SIZE LESION IN THE 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. AFTER RESECTION OF THE LESION, THE PERFORATION WAS RECOGNIZED. THEREFORE COLONIC SURGERY BECAME NECESSARY. THE PATIENT RECOVERED UNEVENTFULLY.

Additional Manufacturer Narrative

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