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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
Catalog Number 72201092
Device Problem Connection Problem (2900)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/01/2017
Event Type  malfunction  
Manufacturer Narrative
The reported device was received for evaluation. There was a relationship found between the returned device and the reported incident. Visual inspection of the returned device noted the guide key in the connector is bent. Functional evaluation could not be performed due to the damaged connector. The complaint was confirmed. Factors which could have contributed to the event include improper installation into the control unit receptacle or attempting to install the footswitch to an incompatible control unit causing distortion or deformation to the guide key tab. This complaint investigation has concluded that the device has exceeded its recommended service life limit and has succumbed to expected wear and tear since the unit has been in service for almost 3 years.
 
Event Description
It was reported that the footswitch, dyonics power ii had connection issues. No backup was available. No patient injuries or complications were reported as a result.
 
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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 73107 6512
Manufacturer (Section G)
SMITH & NEPHEW, INC.
76 s. meridian ave.
oklahoma city OK 73107 6512
Manufacturer Contact
jim gonzales
7000 w william cannon drive
austin, TX 78735
MDR Report Key6674607
MDR Text Key115120423
Report Number1643264-2017-00365
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 company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/07/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/28/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number72201092
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/08/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/30/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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