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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. RFB, DYONICS POWER II CONTROL UNIT ARTHROSCOPE

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SMITH & NEPHEW, INC. RFB, DYONICS POWER II CONTROL UNIT ARTHROSCOPE Back to Search Results
Catalog Number 72200873F
Device Problems No Display/Image (1183); Device Inoperable (1663)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/13/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported the dyonics power ii controller presented a white screen on start-up and was not functioning. A backup was available to complete the procedure. There was no reported delay in the procedure or patient impact associated with this event.
 
Manufacturer Narrative
Device investigation narrative - the subject device was not returned for evaluation to the designated complaint unit, thus visual inspection and functional testing could not be performed. A relationship, if any, between the subject device and the reported event could not be determined since the product was not returned for evaluation. Factors unrelated to the manufacturing and design of the device, which could have contributed to the reported event, includes a defective control board or power supply. Manufacturing records show that the refurbished device was released to distribution on january of 2016. There are no indications to suggest that the product did not meet manufacturing specification when released to distribution. No containment or corrective actions are recommended at this time. If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation. (b)(4).
 
Manufacturer Narrative
Complaint of white screen on power up was confirmed. Cause of display malfunction is a defective display assembly. The complaint investigation has concluded the cause of the failure to be a defective electronic component.
 
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Brand NameRFB, DYONICS POWER II CONTROL UNIT
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
james gonzales
7000 west william cannon drive
austin, TX 78735
5123585706
MDR Report Key6002832
MDR Text Key57255502
Report Number1643264-2016-00186
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 user facility
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 05/18/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/06/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number72200873F
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/10/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/05/2016
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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