UNIVERSAL SCISSORS BLUE 180MM
Received Jun 5, 2020 · Event occurred May 8, 2020
Report 9610612-2020-00201 · MDR key 10124531
Device
Generic name
General Surgical Instruments
Manufacturer
Aesculap AgModel number
BC981RCatalog number
BC981R
Product problems
- Scratched Material
- Scratched Material
Patient
Not reported
- Abrasion
- Abrasion
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.
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 PATIENT HARM. ADDITIONAL INFORMATION WAS NOT PROVIDED NOR AVAILABLE / WAS NOT AVAILABLE. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER (B)(4) REFERENCE (B)(4).