KONIG
Received Jul 22, 2026 · Event occurred Jul 1, 2026
Report 1417592-2026-07290 · MDR key 25907182
Device
Generic name
Handle,knife,scalpel,3,graduated,5
Manufacturer
Medline Industries, LpCatalog number
MDS0610301
Lot number
644
Product problems
- Detachment of Device or Device Component
- Difficult or Delayed Separation
Patient
NA · Unknown
- Laceration(s)
Narrative
Description of Event or Problem
IT WAS REPORTED THAT, "ATTACHING AND REMOVING THE BLADE FROM THE HANDLE IS INCREDIBLY DIFFICULT".
Additional Manufacturer Narrative
IT WAS REPORTED THAT, "ATTACHING AND REMOVING THE BLADE FROM THE HANDLE IS INCREDIBLY DIFFICULT". DUE TO THIS ISSUE, A STAFF MEMBER WAS "CUT TRYING TO REMOVE THE BLADE FROM THE HANDLE, RESULTING IN STITCHES". DUE DILIGENCE HAS BEEN COMPLETED. NO ADDITIONAL DETAILS ARE AVAILABLE RELATED TO THE CUSTOMER REPORTED ISSUE. IT HAS BEEN DETERMINED THAT THOUGH THE EVENT DID NOT INVOLVE A DEATH OR SERIOUS INJURY, RECURRENCE COULD CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY. BASED ON THE INFORMATION REVIEWED, THIS IS A REPORTABLE EVENT AS DEFINED UNDER 21 CFR 803.3.