MalfunctionEIX
AD SURGICAL EXPLORER AND PROBE
Received May 5, 2021 · Event occurred May 3, 2021
Report MW5101208 · MDR key 11783265
Device
Product problems
- Device Reprocessing Problem
Patient
1 DA
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
SINGLE USE ITEM AT THE WEBSITE HTTPS://WWW.AD-SURGICAL.COM/D002-008-P-EXPLORER-AND-PROBE/ IS AN ITEM THAT TOUCHES ORAL MUCOSA. SPECIFICALLY, THE BLACK AND WHITE PORTION MAY BE INSERTED INTO THE PERIODONTAL POCKET. COULD NOT GET RESPONSE FROM COMPANY IF ITEM IS HIGH LEVEL DISINFECTED PRIOR TO PACKAGING. A STERILE OPTION D002-009 IS AVAILABLE BUT D002-008 IS NOT STERILE. FDA SAFETY REPORT ID # (B)(4).