LEICA M530 OH6

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 2016-09-30 for LEICA M530 OH6 manufactured by Leica Microsystems (schweiz) Ag.

Event Text Entries

[55988104] An investigation of the incident is currently underway and a follow up will be submitted should additional information become available following the investigation. Further investigation is required to determine if the device may have caused or contributed to the serious injury.
Patient Sequence No: 1, Text Type: N, H10


[55988105] Leica microsystems (b)(4) received a complaint on (b)(6), 2016 from (b)(6) stating that the surgeon suspects the high temperature of leica m530 oh6 surgical microscope xenon lamp is the root cause that allegedly caused a patient (pt-1-jp) to go blind after neurosurgery. Further investigation is required to determine if the device may have caused or contributed to the serious injury.
Patient Sequence No: 1, Text Type: D, B5


[117489150] This is a final report. Investigations have been conducted by the specification developer. The actual device was evaluated and there is no indication that the device is not functioning as expected. A review of the manufacturing and production records of the affected was also performed. Based on the results, all tested parameters as required in the records were within specification. The complaint database was also reviewed and there was no similar or identical complaints indicating a blindness or damage to the eyesight in any of the complaints. In addition, a simulated use testing was conducted. Furthermore, clinical experts were questioned / interviewed to evaluate if the alleged complaint can be confirmed. Based on the result of the simulated use testing and the interview with the clinical experts, it is unlikely that the heat from the surgical microscope illumination could cause damage to the optical nerve as alleged by the complainant. Based on the results of various investigations, the alleged complaint cannot be confirmed. Therefore, it can be concluded that the affected device operated within specification and that the affected device did not contribute or cause to the adverse event (loss of vision).
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3003974370-2016-00010
MDR Report Key5989705
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2016-09-30
Date of Report2016-09-23
Date of Event2016-09-14
Date Mfgr Received2016-09-23
Device Manufacturer Date2015-10-08
Date Added to Maude2016-09-30
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, ST. GALLEN 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 M530 OH6
Generic NameLEICA M530 OH6
Product CodeEPT
Date Received2016-09-30
Model NumberM530 OH6
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, ST. GALLEN 9435 SZ 9435


Patients

Patient NumberTreatmentOutcomeDate
101. Deathisabilit 2016-09-30

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