LEICA M530 OHX

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 2017-08-15 for LEICA M530 OHX manufactured by Leica Microsystems (schweiz) Ag.

Event Text Entries

[83009974] An investigation of the incident is currently underway and a follow-up will be submitted should additional information become available following investigation.
Patient Sequence No: 1, Text Type: N, H10


[83009975] Leica microsystems received a complaint on (b)(6) 2017 from (b)(6) stating that the main light failed during surgery. When switching to the back-up illumination, it did not work. The system was switched off and on again. After the restart, both lamps did work. There was no patient injury reported. The surgery was completed with the same device.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3003974370-2017-00009
MDR Report Key6796384
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2017-08-15
Date of Report2017-12-11
Date of Event2017-07-18
Date Mfgr Received2017-07-18
Device Manufacturer Date2016-12-09
Date Added to Maude2017-08-15
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
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 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 M530 OHX
Generic NameSURGICAL MICROSCOPE
Product CodeEPT
Date Received2017-08-15
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerLEICA MICROSYSTEMS (SCHWEIZ) AG
Manufacturer AddressMAX SCHMIDHEINY STRASSE 201 HEERBRUGG, 9435 SZ 9435


Patients

Patient NumberTreatmentOutcomeDate
10 2017-08-15

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