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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FOOTSWITCH DYONICS POWER II ARTHROSCOPE

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SMITH & NEPHEW, INC. FOOTSWITCH DYONICS POWER II ARTHROSCOPE Back to Search Results
Model Number 72201092
Device Problem Defective Device (2588)
Patient Problem No Patient Involvement (2645)
Event Date 06/04/2020
Event Type  malfunction  
Event Description
It was reported that the footswitch was not working, when the foot pedal is pressed nothing happens. No case reported; therefore, there was no patient involvement. All available information has been disclosed. If additional information should become available, a supplemental report will be submitted accordingly.
 
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Brand NameFOOTSWITCH DYONICS POWER II
Type of DeviceARTHROSCOPE
Manufacturer (Section D)
SMITH & NEPHEW, INC.
76 s. meridian ave.
oklahoma city, ok
Manufacturer (Section G)
SMITH & NEPHEW, INC.
76 s. meridian ave.
oklahoma city, ok
Manufacturer Contact
holly topping
7000 west william cannon drive
austin, tx 
3913905
MDR Report Key10230798
MDR Text Key198120564
Report Number1643264-2020-00405
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K062849
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 07/30/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/03/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number72201092
Device Catalogue Number72201092
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/22/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/27/2020
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 Unkown

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