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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LEICA MICROSYSTEMS SCHWEIZ AG LEICA M5200 OH3; MICROSCOPE, SURGICAL
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LEICA MICROSYSTEMS SCHWEIZ AG LEICA M5200 OH3; MICROSCOPE, SURGICAL Back to Search Results
Model Number M520 OH3
Device Problems Electrical /Electronic Property Problem (1198); Material Frayed (1262)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/14/2014
Event Type  malfunction  
Event Description
On (b)(4), leica microsystems ((b)(4)) received a complaint stating that during a surgical procedure, the operating staff saw smoke coming from the microscope specifically on the fiber cable.As the fiber cable was damaged, the exposure of the fibers to the insulation cause an overheating.The operating room staff removed the microscope because there was no illumination available.They completed the surgery by using another surgical microscope.
 
Manufacturer Narrative
An investigation of the incident is currently underway and a follow up will be submitted should additional information become available following the investigation.
 
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Brand Name
LEICA M5200 OH3
Type of Device
MICROSCOPE, SURGICAL
Manufacturer (Section D)
LEICA MICROSYSTEMS SCHWEIZ AG
max schmidheiny strasse 201
heerbrugg 0000 9435
SZ  00009435
Manufacturer Contact
roland jehle
max schmidheinystrasse 201
heerbrugg 00009-435
SZ   00009435
17263216
MDR Report Key4174653
MDR Text Key21495378
Report Number3003974370-2014-00008
Device Sequence Number1
Product Code EPT
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,Company Representative
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 07/14/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/08/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberM520 OH3
Was Device Available for Evaluation? Yes
Date Manufacturer Received07/14/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/20/2005
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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