Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DYONICS POWER CONTROL UNIT; ARTHROSCOPE
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SMITH & NEPHEW, INC. DYONICS POWER CONTROL UNIT; ARTHROSCOPE Back to Search Results
Catalog Number 7205841
Device Problem Smoking (1585)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/14/2015
Event Type  malfunction  
Event Description
During an unknown procedure, the dyonics power control unit while using the device, it was reported that the unit smoked when powered on this morning; it appears a board has been damaged.There was no reported patient injury or surgical complication.
 
Manufacturer Narrative
Method, conclusion : no product returned for evaluation.Evaluation of the dyonics power control unit is not possible as the device has not been returned.(b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
DYONICS POWER CONTROL UNIT
Type of Device
ARTHROSCOPE
Manufacturer (Section D)
SMITH & NEPHEW, INC.
76 s. meridian ave.
oklahoma city OK 73107 651
Manufacturer (Section G)
SMITH & NEPHEW, INC.
76 s. meridian ave.
oklahoma city OK 73107 651
Manufacturer Contact
jim gonzales
150 minuteman road
andover, MA 01810
5123585706
MDR Report Key4949279
MDR Text Key22163946
Report Number1643264-2015-00083
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K030196
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 07/28/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/29/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number7205841
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/28/2015
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/08/2000
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
-
-