inforMED
FAM

FLEX SHAFT II

Received Aug 18, 2006 · Event occurred Jun 1, 2006

Report 761903 · MDR key 761903

Device

Generic name

Sigmoid Scope

Model number

FLEX SHAFT II

Catalog number

*

Lot number

*

Product problems

  • Device Reprocessing Problem
  • Sterility
  • Use of Device Problem

Patient

76 YR

  • Unknown (for use when the patient's condition is not known)

Narrative

Description of Event or Problem

DURING PROCEDURE SALES REPRESENTATIVE INFORMED US THAT THE FLEXIBLE SHAFT II SIGMOID SCOPE WAS NOT CLEANED ACCORDING TO MANUFACTURER'S RECOMMENDATIONS. OUR STANDARD PROCEDURE HAS BEEN TO FLASH AUTOCLAVE FOR 3 MINUTES. FLASH STERILIZATION SHOULD NOT BE DONE. SCOPE SHOULD BE AUTOCLAVED FOR STANDARD TIME.