• 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 CABLE ASSEMBLY SAW, POWERED, AND ACCESSORIES

  • 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 CABLE ASSEMBLY SAW, POWERED, AND ACCESSORIES Back to Search Results
Model Number 7205788
Device Problems Power Cord (497); Electrical Shorting (2926)
Patient Problem No Patient Involvement (2645)
Event Date 08/29/2018
Event Type  Malfunction  
Event Description

It was reported that there was a short-circuit in the electrical power supply cord. Event occur before a case.

 
Manufacturer Narrative

The device was received for evaluation. There was no relationship found between the returned device and the reported incident. A visual inspection observed a broken pin and corroded sockets in the hand piece connector. A functional test revealed the device did not allow the hand piece to be recognized or operated. The reported malfunction was not observed during functional evaluation. A review of the device history records show there are no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended. The complaint was not confirmed.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameDYONICS POWER CABLE ASSEMBLY
Type of DeviceSAW, POWERED, AND ACCESSORIES
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 west william cannon drive
austin, TX 78735
5123585706
MDR Report Key7883005
MDR Text Key120572927
Report Number1643264-2018-00714
Device Sequence Number1
Product Code HAB
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberEXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 10/24/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/17/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number7205788
Device Catalogue Number7205788
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/13/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/23/2018
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

-
-