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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LIGHT SOURCE 500XL XENON IMAGE, ILLUMINATION, FIBEROPTIC, FOR ENDOSCOPE

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SMITH & NEPHEW, INC. LIGHT SOURCE 500XL XENON IMAGE, ILLUMINATION, FIBEROPTIC, FOR ENDOSCOPE Back to Search Results
Model Number 72200568
Device Problem Power Problem (3010)
Patient Problem No Patient Involvement (2645)
Event Date 01/01/1901
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 found the front bezel cracked. A functional evaluation revealed the unit will not power up. The complaint was confirmed and the root cause was associated with 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 concluded this was a repeat issue.
 
Event Description
It was reported that the light source power supply was not working. No case reported; therefore, there was no patient involvement. Results of investigation have concluded that this unit will not power up which makes it a reportable event.
 
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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
Manufacturer (Section G)
SMITH & NEPHEW, INC.
76 s. meridian ave.
oklahoma city OK 73107
Manufacturer Contact
holly topping
7000 west william cannon drive
austin, TX 78735
5123913905
MDR Report Key10838700
MDR Text Key216332303
Report Number1643264-2020-01823
Device Sequence Number1
Product Code FFS
Combination Product (y/n)N
Reporter Country CodeJA
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 11/13/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/13/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number72200568
Device Catalogue Number72200568
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/22/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/09/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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