ARTHROSCOPIC SHAVERS
Received Jul 17, 2018 · Event occurred Jun 26, 2018
Report 3032391-2018-00007 · MDR key 7694862
Device
Generic name
Dyonics Razor Cut Blade (pink) 4.5mm
Manufacturer
Medline RenewalCatalog number
7205318RH
Lot number
385352
Product problems
- Flaked
Patient
Not reported
- Foreign Body In Patient
- Foreign Body In Patient
Narrative
Additional Manufacturer Narrative
IT WAS REPORTED THAT A REPROCESSED DYONIC RAZOR CUT BLADE HAD METAL SHAVINGS WHICH GOT TO THE PATIENT DURING USE FOR AN UNIDENTIFIED PROCEDURE. REPORTEDLY, THE SURGEON WAS NOT ABLE TO RETRIEVE THE METAL SHAVINGS FROM THE PATIENT. THERE WAS NO REPORTED IMPACT TO THE PATIENT AS RESULT OF THE EVENT. ANOTHER DEVICE WAS OPENED AND THE PROCEDURE CONTINUED WITHOUT FURTHER INCIDENT. THERE WAS NO REPORT OF AN ADVERSE PATIENT CONSEQUENCE OR NEED FOR MEDICAL INTERVENTION AS A RESULT OF THIS EVENT. DUE TO THE REPORTED INCIDENT AND IN AN ABUNDANCE OF CAUTION, MEDLINE RENEWAL IS FILING THIS MEDWATCH REPORT. THE SAMPLE WAS NOT RETURNED FOR EVALUATION. A ROOT CAUSE COULD NOT BE DETERMINED AT THIS TIME. NO ADDITIONAL INFORMATION IS AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE FILED.
Description of Event or Problem
IT WAS REPORTED THAT A REPROCESSED DYONIC RAZOR CUT BLADE HAD METAL SHAVINGS WHICH GOT TO THE PATIENT DURING USE FOR AN UNIDENTIFIED PROCEDURE.