inforMED
MalfunctionGES

MEDLINE

Received Jun 30, 2026 · Event occurred Jun 4, 2026

Report 1417592-2022-03549 · MDR key 25664652

Device

Generic name

Dbd-blade,stainless-steel,15,strl,dispos

Catalog number

CISION15SSH

Lot number

C01020

Product problems

  • Difficult to Insert
  • Difficult to Remove

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

IT WAS REPORTED THAT STAFF AND PROVIDERS HAVE STATED THAT THESE BLADES ARE EXTREMELY DIFFICULT TO ATTACH TO AND REMOVE FROM THE BLADE HANDLE. THERE WERE NO REPORTS OF DEATH, SERIOUS INJURY, MEDICAL INTERVENTION, OR FOLLOW UP CARE. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT COULD CAUSE OR CONTRIBUTE TO SERIOUS INJURY IF IT WERE TO OCCUR AGAIN. IN AN ABUNDANCE OF CAUTION, THIS IS A REPORTABLE EVENT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THIS REPORT WILL BE REOPENED AND REEVALUATED.

Description of Event or Problem

IT WAS REPORTED THAT STAFF AND PROVIDERS HAVE STATED THAT THESE BLADES ARE EXTREMELY DIFFICULT TO ATTACH TO AND REMOVE FROM THE BLADE HANDLE.