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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SVCE REPL LIGHT SOURCE LED 3000; IMAGE, ILLUMINATION, FIBEROPTIC, FOR ENDOSCOPE
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SMITH & NEPHEW, INC. SVCE REPL LIGHT SOURCE LED 3000; IMAGE, ILLUMINATION, FIBEROPTIC, FOR ENDOSCOPE Back to Search Results
Catalog Number 72204011S
Device Problem Failure to Power Up (1476)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Event Description
It was reported that the light source didn't turn on during a routine inspection.The malfunction was solved with no delays or patient harm using a back up device.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
 
Manufacturer Narrative
The device, which was not used in a procedure, was returned for evaluation.There was a relationship between the reported event and the device.A visual assessment of the light source showed the top, bottom, and rear cover are dented and damaged.The stand by button is worn and the on/off switch is damaged.This failure is confirmed not to originate from manufacturing, packaging, or labeling defects.This failure is caused by contact with another source and wear from use.A review of the manufacturing records found that there was no evidence that the product didn¿t meet specifications at the time of manufacture.A complaint history review found other related failures.No manufacturing related defects were observed.
 
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Brand Name
SVCE REPL LIGHT SOURCE LED 3000
Type of Device
IMAGE, ILLUMINATION, FIBEROPTIC, FOR ENDOSCOPE
Manufacturer (Section D)
SMITH & NEPHEW, INC.
150 minuteman road
andover MA 01810
MDR Report Key10639060
MDR Text Key213025504
Report Number3003604053-2020-00118
Device Sequence Number1
Product Code FFS
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Type of Report Initial,Followup
Report Date 10/26/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/06/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number72204011S
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/28/2020
Date Manufacturer Received09/14/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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