inforMED
MalfunctionFAM

KIT SIGMOIDOSCOPE LIGHTED SGL USE STRL

Received Mar 9, 2026 · Event occurred Feb 23, 2026

Report MW5184910 · MDR key 24547477

Device

Generic name

Sigmoidoscope And Accessories, Flexible/rigid

Manufacturer

Bioseal

Lot number

400763

Patient

65 YR · Female

  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

DISPOSABLE SIGMOIDOSCOPE WAS BEING USED, AND THE "WINDOW" POPPED OUT CAUSING INSUFFLATION TO BE LOST. SURGEON NOTED THIS HAS HAPPENED MULTIPLE TIMES. NO HARM TO THE PATIENT. A NON-DISPOSABLE SIGMOIDOSCOPE WAS USED TO COMPLETE THE EXAM.