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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

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SMITH & NEPHEW, INC. SVCE REPL LIGHT SOURCE 500XL XENON IMAGE, ILLUMINATION, FIBEROPTIC, FOR ENDOSCOPE Back to Search Results
Model Number 72200568S
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/04/2018
Event Type  malfunction  
Event Description
It was reported that light will not stay consistent. No back-up device was available. Nor delay or patient injury reported.
 
Manufacturer Narrative
The device was received for evaluation. A visual inspection was performed and no issues were noted. There was a relationship found between the returned device and the reported incident. The complaint of inconsistent light output was confirmed. Cause of inconsistent light output is a worn out lamp. Lamp received with light source has recorded 623 hours of usage. Lamp module should be replaced at 500 hours of usage. Display shows a message of "replace lamp" on power up. Lamp module ignites intermittently on power up and light output is not consistent. Unit passes functional testing with a known good lamp module installed. The complaint investigation has concluded the cause of the failure to be a lamp module that has expired the maximum hours of usage. 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.
 
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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
jim gonzales
7000 west william cannon drive
austin, TX 78735
MDR Report Key7553418
MDR Text Key109671850
Report Number1643264-2018-00424
Device Sequence Number1
Product Code FFS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K994084
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 05/30/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/30/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number72200568S
Device Catalogue Number72200568S
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/14/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/03/2018
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 Reuse

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