UNIVERSAL SCISSORS BLUE 180MM
Received Jun 8, 2020 · Event occurred May 8, 2020
Report 2916714-2020-00186 · MDR key 10130474
Device
Product problems
- Material Protrusion/Extrusion
Patient
Not reported
- Laceration(s)
- Laceration(s)
Narrative
Additional Manufacturer Narrative
INVESTIGATION RESULTS: NO DEVIATIONS OR BARBS CAN BE FOUND DURING INVESTIGATION. THE CUTTING TESTS HAVE BEEN CARRIED OUT ACCORDING TO THE QUALITY STANDARD SUCCESSFULLY. THE DESCRIBED FAILURE CANNOT BE CONFIRMED. THE FAILURE IS MOST PROBABLY RELATED TO AN INSUFFICIENT USAGE.
Description of Event or Problem
NO UPDATES.
Additional Manufacturer Narrative
MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. ADDITIONAL INFORMATION / INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem
IT WAS REPORTED THAT THERE WAS AN ISSUE WITH UNIVERSAL SCISSORS. IT WAS REPORTED THAT THE SURFACE OF THE DEVICE HAS A METAL BARB. BECAUSE OF THIS MALFUNCTION, A STAFF MEMBER PRICKED A FINGER. THE CUT WAS CLEANED OUT WITH SOAP AND WATER. IT OCCURRED PRIOR TO A SURGERY IN A DIFFERENT UNIT. THERE WAS NO LASTING PATIENT HARM. ADDITIONAL INFORMATION WAS NOT PROVIDED NOR AVAILABLE / WAS NOT AVAILABLE. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER AAG REFERNCE (B)(4).