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 report with the FDA on 2018-02-23 for LEICA M530 OHX manufactured by Leica Microsystems (schweiz) Ag.

Event Text Entries

[100779070] 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


[100779111] (b)(4) received a complaint from usa stating that the power inlet fuse blew during a surgical procedure causing the microscope to power off. The procedure was completed with another surgical microscope. There was no patient injury reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3003974370-2018-00001
MDR Report Key7291546
Report SourceCOMPANY REPRESENTATIVE
Date Received2018-02-23
Date of Report2018-07-06
Date of Event2018-02-08
Date Mfgr Received2018-02-08
Device Manufacturer Date2017-04-12
Date Added to Maude2018-02-23
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, SANKT GALLEN 9435
Manufacturer CountrySZ
Manufacturer Postal9435
Manufacturer G1LEICA INSTRUMENTS (SINGAPORE) PTE LTD
Manufacturer Street12 TEBAN GARDENS CRESCENT
Manufacturer CitySINGAPORE, SINGAPORE 608924
Manufacturer CountrySN
Manufacturer Postal Code608924
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameLEICA M530 OHX
Generic NameSURGIAL MICROSCOPE
Product CodeEPT
Date Received2018-02-23
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, SANKT GALLEN 9435 SZ 9435


Patients

Patient NumberTreatmentOutcomeDate
10 2018-02-23

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