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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LEICA MICROSYSTEMS ( SCHWEIZ) AG LEICA M525 F20; MICROSCOPE, SURGICAL
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LEICA MICROSYSTEMS ( SCHWEIZ) AG LEICA M525 F20; MICROSCOPE, SURGICAL Back to Search Results
Model Number M525 F20
Device Problems Electrical /Electronic Property Problem (1198); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/20/2013
Event Type  malfunction  
Event Description
On (b)(4) 2013, leica microsystems received a complaint stating that the illumination of leica m525 f20 surgical microscope malfunctioned during a surgical procedure (mastoidectomy surgery).Both lamps were not in full intensity and the filter was not in the correct position.The illumination (both modules) switched on and off intermittently during the middle of the surgery.The microscope was replaced during the surgery to continue the procedure.
 
Manufacturer Narrative
Affected device is in evaluation.If additional information becomes available, a follow up report will be submitted to the fda.
 
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Brand Name
LEICA M525 F20
Type of Device
MICROSCOPE, SURGICAL
Manufacturer (Section D)
LEICA MICROSYSTEMS ( SCHWEIZ) AG
max schmidheiny - strasse 201
heerbrugg 9435
SZ  9435
Manufacturer Contact
max schmidheiny - strasse 201
heerbrugg CH - -9435
MDR Report Key3822903
MDR Text Key4399226
Report Number3003974370-2014-00002
Device Sequence Number1
Product Code EPT
Combination Product (y/n)N
Reporter Country CodeRP
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 11/20/2013
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/18/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberM525 F20
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received11/20/2013
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/01/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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