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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DYONICS POWERMINI WITH HAND CONTROLS SAW, POWERED, AND ACCESSORIES

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SMITH & NEPHEW, INC. DYONICS POWERMINI WITH HAND CONTROLS SAW, POWERED, AND ACCESSORIES Back to Search Results
Model Number 72201500
Device Problem Image Display Error/Artifact (1304)
Patient Problem No Patient Involvement (2645)
Event Date 01/01/1901
Event Type  Malfunction  
Event Description

It was reported that the dyonics powermini displayed "unknown handpiece" error message. No case involved. All available information has been disclosed. If additional information should become available, a supplemental report will be submitted accordingly.

 
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Brand NameDYONICS POWERMINI WITH HAND CONTROLS
Type of DeviceSAW, POWERED, AND ACCESSORIES
Manufacturer (Section D)
SMITH & NEPHEW, INC.
76 s. meridian ave.
oklahoma city OK 73107
Manufacturer (Section G)
SMITH & NEPHEW, INC.
76 s. meridian ave.
oklahoma city OK 73107
Manufacturer Contact
holly topping
7000 west william cannon drive
austin, TX 78735
5123913905
MDR Report Key10234273
MDR Text Key197647923
Report Number1643264-2020-00474
Device Sequence Number1
Product Code HAB
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberEXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 10/20/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/06/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number72201500
Device Catalogue Number72201500
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/12/2020
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/13/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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