LEICA M525 F20

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2017-04-27 for LEICA M525 F20 manufactured by Leica Microsystems (schweiz) Ag.

Event Text Entries

[74145953] An investigation of the incident is currently underway and a follow up will be submitted should additional information become available following the investigation.
Patient Sequence No: 1, Text Type: N, H10


[74145954] Leica microsystems (b)(6) received a complaint on april 10, 2017 from (b)(6) stating that during an endodontic surgery, the user heard a noise coming from the stand. The lamp went out. As there was only one lamp mounted, the microscope had no light at all. The procedure was completed with another microscope.
Patient Sequence No: 1, Text Type: D, B5


[75938091] The affected part was not returned to the manufacturer because it has been discarded by the dealer's engineer. Therefore, an evaluation cannot be performed and the device's problem cannot be confirmed. Affected part has been discarded.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3003974370-2017-00006
MDR Report Key6525788
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2017-04-27
Date of Report2017-04-10
Date of Event2017-04-09
Date Mfgr Received2017-04-10
Device Manufacturer Date2012-06-27
Date Added to Maude2017-04-27
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationBIOMEDICAL ENGINEER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. ROLAND JEHLE
Manufacturer StreetMAX SCHMIDHEINY STRASSE 201
Manufacturer CityHEERBRUGG, 9435
Manufacturer CountrySZ
Manufacturer Postal9435
Manufacturer Phone717263216
Manufacturer G1LEICA INSTRUMENTS (SINGAPORE) PTE LTD
Manufacturer Street12 TEBAN GARDENS CRESCENT
Manufacturer CitySINGAPORE, 608924
Manufacturer CountrySN
Manufacturer Postal Code608924
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameLEICA M525 F20
Generic NameSURGICAL MICROSCOPE
Product CodeEPT
Date Received2017-04-27
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerLEICA MICROSYSTEMS (SCHWEIZ) AG
Manufacturer AddressMAX SCHMIDHEINY STRASSE 201 HEERBRUGG, 9435 SZ 9435


Patients

Patient NumberTreatmentOutcomeDate
10 2017-04-27

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