inforMED
MalfunctionGDZ

#11 SAFETY SCALPEL, NS, #11 NEW DESIGN, BULK, NS

Received Jun 25, 2026 · Event occurred May 21, 2026

Report 1123071-2026-00001 · MDR key 25620320

Device

Generic name

Handle, Scalpel

Model number

D4511A

Product problems

  • Dull, Blunt

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

A DISTRIBUTING FACILITY REPORTED, "WE WERE NOTIFIED OF A COMPLAINT FROM A CUSTOMER STATING DULL INSTRUMENTS."

Additional Manufacturer Narrative

A DISTRIBUTING FACILITY REPORTED, "WE WERE NOTIFIED OF A COMPLAINT FROM A CUSTOMER STATING DULL INSTRUMENTS." DEROYAL INDUSTRIES, INC. REQUESTED RETURN OF THE DEVICE, HOWEVER IT WAS STATED TO BE UNAVAILABLE. THE INVESTIGATION IS NOT COMPLETE AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WE WILL PROVIDE FOLLOW-UP REPORT WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.