• 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. LIGHT SOURCE, 500XL, XENON IMAGE, ILLUMINATION, FIBEROPTIC, FOR ENDOSCOPE

  • 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. LIGHT SOURCE, 500XL, XENON IMAGE, ILLUMINATION, FIBEROPTIC, FOR ENDOSCOPE Back to Search Results
Catalog Number 72200568
Device Problems Device Emits Odor (1425); Noise, Audible (3273)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/01/1901
Event Type  malfunction  
Manufacturer Narrative
(b)(6).
 
Event Description
It was reported that a burning smell was noted after hearing a loud sounding beep. This all took place before a procedure so there is no patient involvement. Additionally, there is no reported injury to staff or property.
 
Manufacturer Narrative
Complaint of burning smell and loud noise was confirmed. Cause of burning smell and loud noise is a defective power supply/ballast. Unit powered up and passed functional testing with a known good power supply installed. The complaint investigation has concluded the cause of the failure to be a defective electronic component. No containment or corrective actions are recommended at this time. A review of the device history record was performed which confirmed no inconsistencies.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameLIGHT SOURCE, 500XL, XENON
Type of DeviceIMAGE, ILLUMINATION, FIBEROPTIC, FOR ENDOSCOPE
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 w. william cannon drive
austin, TX 78735
MDR Report Key6503213
MDR Text Key73378768
Report Number1643264-2017-00214
Device Sequence Number1
Product Code FFS
Combination Product (y/n)N
PMA/PMN Number
K994084
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/27/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/19/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number72200568
Device Lot NumberBBR0186
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/04/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/27/2017
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 Reuse

-
-