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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA YORK, PA INC. MLX 300W XENON LIGHTSOURCE; N/A
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INTEGRA YORK, PA INC. MLX 300W XENON LIGHTSOURCE; N/A Back to Search Results
Catalog Number 00MLX
Device Problem Excessive Heating (4030)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.
 
Event Description
A customer reported that the 00mlx mlx 300w xenon lightsource has a fan issue and overheats.There was no known patient contact or surgery delay.
 
Event Description
N/a.
 
Manufacturer Narrative
Unique device identifier (udi): (b)(4).Dhr review: dhr shows no abnormalities related to the reported issue.The returned 00mlx light source was in used condition with a disconnected connection on the fan preventing proper function.The reported complaint is confirmed.No further investigation required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.
 
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Brand Name
MLX 300W XENON LIGHTSOURCE
Type of Device
N/A
Manufacturer (Section D)
INTEGRA YORK, PA INC.
589 davies drive
589 davies drive
york PA 17402
MDR Report Key10675424
MDR Text Key211227593
Report Number2523190-2020-00116
Device Sequence Number1
Product Code FCW
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
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 09/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/13/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number00MLX
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/18/2020
Date Manufacturer Received11/17/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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