KONIG
Received Jul 21, 2026 · Event occurred Jul 1, 2026
Report 1417592-2026-07445 · MDR key 25898799
Device
Generic name
Handle,knife,scalpel,3,graduated,5
Manufacturer
Medline Industries, LpCatalog number
MDS0610301
Lot number
644
Product problems
- Difficult to Insert
- Device Difficult to Setup or Prepare
- Difficult to Remove
- Activation, Positioning or Separation Problem
Patient
NA · Unknown
- Hemorrhage/Blood Loss/Bleeding
Narrative
Additional Manufacturer Narrative
ACCORDING TO THE CUSTOMER CONTACT, "ATTACHING AND REMOVING THE BLADE FROM THE HANDLE IS INCREDIBLY DIFFICULT. TWO INCIDENTS WHERE STAFF WHERE CUT TRYING TO REMOVE THE BLADE FROM THE HANDLES, RESULTING IN STICHES FOR BOTH CLINICIANS." CUSTOMER BELIEVES THIS ISSUE WAS CAUSED BY THIS PRODUCT BEING THICKER AND BULKIER THAN ANOTHER DEVICE. DUE DILIGENCE HAS BEEN COMPLETED. NO ADDITIONAL DETAILS ARE AVAILABLE RELATED TO THE CUSTOMER REPORTED ISSUE. DESPITE MULTIPLE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE CUSTOMER CONTACT WAS UNABLE OR UNWILLING TO PROVIDE FURTHER INCIDENT DETAILS TO THE MANUFACTURER. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY. BASED ON THE INFORMATION REVIEWED, THIS IS A REPORTABLE EVENT AS DEFINED UNDER 21 CFR 803.3.
Description of Event or Problem
ACCORDING TO THE CUSTOMER CONTACT, "ATTACHING AND REMOVING THE BLADE FROM THE HANDLE IS INCREDIBLY DIFFICULT. TWO INCIDENTS WHERE STAFF WHERE CUT TRYING TO REMOVE THE BLADE FROM THE HANDLES, RESULTING IN STICHES FOR BOTH CLINICIANS."