360 DEGREE SCALPEL HANDLE
Received Jul 13, 2022 · Event occurred Jun 9, 2022
Report 1416605-2022-00008 · MDR key 15008798
Device
Generic name
Scalpel Handle
Manufacturer
Hu-friedy Mfg. Co. LlcModel number
K360Catalog number
K360
Lot number
0322
Product problems
- Detachment of Device or Device Component
- Detachment of Device or Device Component
Patient
Unknown
- Laceration(s)
- Laceration(s)
Narrative
Description of Event or Problem
THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE WHICH INCLUDED USE OF A 360 DEGREE SCALPEL HANDLE, PART OF THE HANDLE DETACHED AND THE PATIENT OBTAINED A CUT.
Additional Manufacturer Narrative
HU-FRIEDY HAS CONTACTED THE CUSTOMER TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT AND REQUESTED THE DEVICE TO BE RETURNED FOR EVALUATION. THE INVESTIGATION INTO THE REPORTED EVENT IS IN PROCESS; A FOLLOW-UP MDR WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.
Additional Manufacturer Narrative
BASED ON THE INVESTIGATION PERFORMED BY HU-FRIEDY, THE TIP OF THE 360 DEGREE SCALPEL HANDLE SEPARATED DUE TO PRODUCTION PERSONNEL OVER BUFFING THE HANDLE DURING THE PRESS FITTING PROCESS. THE DEVICE SUBJECT OF THE EVENT WAS RETURNED TO HU-FRIEDY.