inforMED
InjuryFDF

FLEXIBLE PEDIATRIC COLONOSCOPE

Received Jun 10, 2025

Report MW5171218 · MDR key 22177165

Device

Generic name

Colonoscope And Accessories, Flexible/rigid

Model number

PCF-H190L

Product problems

  • Contamination
  • Mechanical Problem
  • Material Separation

Patient

NA · Unknown

  • Hemorrhage/Blood Loss/Bleeding
  • Hemorrhage/Blood Loss/Bleeding

Narrative

Description of Event or Problem

DURING AN OUTPATIENT PROCEDURE, THE FLEXIBLE SIGMOIDOSCOPY FAILED TO RETROFLEX INTO THE RECTUM. BRIEF TROUBLESHOOTING WAS PERFORMED WITHOUT SUCCESS AND THE DEVICE WAS WITHDRAWN, AT WHICH TIME IT WAS NOTICED THAT THE FLEXIBLE RUBBER SHEATH TOWARDS THE TIP OF THE SCOPE HAD DEGLOVED FROM THE REST OF THE SCOPE, EXPOSING SOME METAL AND INTERNAL NON-STERILE PARTS OF THE SCOPE. THE SCOPE WAS REMOVED FROM SERVICE. THE PROVIDER INTRODUCED A WORKING SCOPE INTO THE PATIENT'S RETURN TO ASSESS POTENTIAL DAMAGE AND DID NOT SEE ANY MUCOSAL INJURY BUT THERE WAS A SMALL AMOUNT OF BLOOD IN THE RECTUM AND EXTERNALLY WHICH THE PROVIDER ATTRIBUTED WAS LIKELY DUE TO THE PATIENT'S EXTERNAL HEMORRHOIDS. THE PATIENT WAS DISCHARGED AFTER THE PROCEDURE.