MAUDE Adverse Event Report: AD SURGICAL /APPLIED DENTAL INC. DBA AD SURGICAL AD SURGICAL EXPLORER AND PROBE; PROBE, PERIODONTIC

Catalog Number D002-008P

Device Problems Inadequate Instructions for Healthcare Professional (1319); Delivered as Unsterile Product (1421)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

(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).

• Brand Name: AD SURGICAL EXPLORER AND PROBE
• Type of Device: PROBE, PERIODONTIC
• Manufacturer (Section D): AD SURGICAL /APPLIED DENTAL INC. DBA AD SURGICAL ; sunnyvale CA 94086
• MDR Report Key: 11313391
• MDR Text Key: 231657664
• Report Number: MW5099337
• Device Sequence Number: 1
• Product Code: EIX
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 02/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: D002-008P
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1