MalfunctionGDZ

SKYLARSAFE SAFETY SCALPEL

Received Sep 9, 2019 · Event occurred Aug 3, 2019

Report 8974756 · MDR key 8974756

Device

Generic name

Scalpel, Handle

Manufacturer

Sklar Corporation

Lot number

01200546

Product problems

Device Fell

Patient

0 DA

No Consequences Or Impact To Patient
No Consequences Or Impact To Patient

Narrative

Description of Event or Problem

THE SAFETY COVER FELL OFF THE DEVICE AFTER BEING USED ON THE PATIENT. REPORTEDLY, THE COVER FELL OFF WHEN THE PHYSICIAN PICKED UP THE DEVICE. STAFF REPORTED IT WAS "LIKE IT WAS NEVER LOCKED AND COULDN'T BE LOCKED". NO HARM OCCURRED, BUT THIS LEFT THE BLADE EXPOSED.