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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
Catalog Number 72200568
Device Problem Insufficient Information (3190)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/11/2019
Event Type  malfunction  
Event Description
It was reported that during an acl procedure, the light source shut off.The procedure was successfully completed using a back-up device.There was a delay greater than 30 minutes.No patient injury or other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
 
Manufacturer Narrative
H3, h6: the reported device, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.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.A relationship, if any, between the subject device and the reported event could not be determined.No containment or corrective actions are recommended at this time.
 
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Brand Name
LIGHT SOURCE, 500XL, XENON
Type of Device
IMAGE, ILLUMINATION, FIBEROPTIC, FOR ENDOSCOPE
Manufacturer (Section D)
SMITH & NEPHEW, INC.
76 s. meridian ave.
oklahoma city OK 73107 6512
MDR Report Key9428898
MDR Text Key169715775
Report Number1643264-2019-00857
Device Sequence Number1
Product Code FFS
UDI-Device Identifier03596010643070
UDI-Public03596010643070
Combination Product (y/n)N
PMA/PMN Number
K994084
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 01/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number72200568
Device Lot NumberBBR8845
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 11/11/2019
Initial Date FDA Received12/06/2019
Supplement Dates Manufacturer Received01/08/2020
Supplement Dates FDA Received01/09/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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