MalfunctionEIX
AD SURGICAL EXPLORER AND PROBE
Received Feb 10, 2021
Report MW5099337 · MDR key 11313391
Device
Generic name
Probe, Periodontic
Manufacturer
Ad Surgical /applied Dental Inc. Dba Ad SurgicalCatalog number
D002-008P
Product problems
- Inadequate Instructions for Healthcare Professional
- Delivered as Unsterile Product
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
(B)(6) IS CURRENTLY SELLING NON-STERILE SINGLE USE BDS KITS (EXPLORER AND PROBES). THE KITS ARE DESIGNATED TO BE USED FOR SIMPLE EXAMS, EMERGENCIES AND OTHER TYPES OF APPOINTMENTS. THE ISSUE IS THESE ITEMS ARE CLASSIFIED AS SEMI-CRITICAL ITEMS AND REQUIRE A STERILIZATION PROCESS BEFORE USE ON PATIENTS. THE COMPANY HAS STATED THEY ARE NON-STERILE AND THEY DO NOT PROVIDE STERILIZATION INSTRUCTION AS REQUIRED BY CDC. FDA SAFETY REPORT ID # (B)(4).