inforMED
MalfunctionHFW

MEDLINE

Received May 28, 2026 · Event occurred Apr 1, 2026

Report 1417592-2026-01897 · MDR key 25326008

Device

Generic name

Cutter,cord Clamp,waller,tc,5"

Catalog number

MDS6622300

Product problems

  • Material Puncture/Hole
  • Detachment of Device or Device Component

Patient

NA · Unknown

  • Insufficient Information

Narrative

Additional Manufacturer Narrative

IT WAS REPORTED THAT THE CUTTER IS EXPERIENCING GOUGING ON THE BLADES AND SPRINGS ARE COMING LOOSE ON THE HANDLES. 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 HAS BEEN REPORTED THAT THE CUTTER IS EXPERIENCING GOUGING ON THE BLADES AND SPRINGS ARE COMING LOOSE ON THE HANDLES.