inforMED
MalfunctionFDF

COLONOSCOPE

Received May 7, 2025 · Event occurred Apr 15, 2025

Report MW5170042 · MDR key 21976989

Device

Generic name

Colonoscope And Accessories, Flexible/rigid

Product problems

  • Device Reprocessing Problem
  • Inadequate or Insufficient Training
  • Microbial Contamination of Device
  • Protective Measures Problem

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

AT APPROXIMATELY 1520 ON (B)(6) 2025, SURGERY NURSE NOTIFIED SPS CHIEF THAT A PATHOLOGIST FROM ANOTHER VA FACILITY CALLED THE GI(GASTROINTESTINAL) PROVIDER TO LET HIM KNOW THAT A SAMPLE FROM A COLONOSCOPY HAD BECOME CONTAMINATED WITH A FUNGUS AND THAT IT WAS THE SECOND TIME IN ONE MONTH. A SEPARATE SAMPLE FROM ANOTHER PATIENT HAD BECOME CONTAMINATED DURING AN EGD(ESOPHAGOGASTRODUODENOSCOPY) COLLECTION. THE PATHOLOGIST WONDERED IF IT MIGHT BE CONTAMINATED FROM THE SCOPE. NURSING LEADERSHIP WAS NOTIFIED, ALONG WITH VISN CHIEF STERILE PROCESSING OFFICER AND VISN INFECTION PREVENTION LEAD. THERE WERE NO ENDOSCOPES SCHEDULED FOR THE NEXT DAY. ON (B)(6) 2025, A MULTIDISCIPLINARY TEAMS CALL WAS HELD. ALL PROCESSES WERE REVIEWED; ADDITIONAL EDUCATION AND CLEANING WERE CONDUCTED. ENDOSCOPES WERE INSPECTED AND ALL PROCESSES RELATED TO ENDOSCOPE CLEANING AND USE WERE REVIEWED. SOME NONCONFORMITIES WERE NOTED DURING BAROSCOPE INSPECTION. SPS CHIEF IS CURRENTLY WORKING TO SEND SAMPLES FOR IDENTIFICATION. SPS WATER TESTING WAS COMPLETED. AWAITING RESULTS. CONTINUING TO ASSESS AND CONSULT SMES TO CREATE SAFE PLAN OF ACTION. REFERENCE REPORT MW5170038, MW5170039, MW5170040, MW5170041, MW5170043, MW5170044, MW5170045, MW5170046.