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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AD SURGICAL AD SURGICAL EXPLORER AND PROBE

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AD SURGICAL AD SURGICAL EXPLORER AND PROBE Back to Search Results
Model Number #D002-008-P
Device Problem Device Reprocessing Problem (1091)
Patient Problem Insufficient Information (4580)
Event Date 05/03/2021
Event Type  malfunction  
Event Description
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).
 
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Brand Name
AD SURGICAL EXPLORER AND PROBE
Type of Device
EXPLORER AND PROBE
Manufacturer (Section D)
AD SURGICAL
sunnyvale CA 94086
MDR Report Key11783265
MDR Text Key249663130
Report NumberMW5101208
Device Sequence Number1
Product Code EIX
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Dentist
Type of Report Initial
Report Date 05/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number#D002-008-P
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received05/05/2021
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age1 DA
Patient Weight5
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