• 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. SVCE REPL 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. SVCE REPL LIGHT SOURCE 500XL XENON IMAGE, ILLUMINATION, FIBEROPTIC, FOR ENDOSCOPE Back to Search Results
Model Number 72200568
Device Problem Insufficient Information (3190)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
The reported device, intended for use in treatment, was received for evaluation. There was a relationship found between the returned device and the reported incident. A visual inspection observed no issue. A functional evaluation revealed the unit will not power up. The complaint was verified and the root cause was associated with electrical component failure. A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended. A complaint history review found related failures; this failure mode will be trended to assess for any necessary corrective actions.
 
Event Description
It was reported that, during incoming inspection, the 500xl xenon light source did not work. No case reported; therefore, there was no patient involvement. Results of investigation have concluded that the unit will not power up which makes it a reportable event. All available information has been disclosed. If additional information should become available, a supplemental report will be submitted accordingly.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSVCE REPL LIGHT 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
hollly topping
7000 west william cannon drive
austin, TX 78735
5123913905
MDR Report Key10446096
MDR Text Key204225257
Report Number1643264-2020-00942
Device Sequence Number1
Product Code FFS
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K994084
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 08/24/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/24/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number72200568
Device Catalogue Number72200568S
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/10/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/21/2020
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 Unkown

-
-