FDA.reportPublic FDA data

MAUDE MDR 6679707

MDR report key
6679707
Report number
9615030-2017-00011
Event key
0
Event type
3
Date of event
2017-04-27
Date received
2017-06-29
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MS. DORENE MARKWIESE
Address
5160 HACIENDA DRIVE DUBLIN CA 94568 US
Phone
925-925-9255
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1MEL80 EXCIMER LASER SYSTEMEXCIMER LASER SYSTEMCARL ZEISS MEDITEC AG (JENA)LZSNA000000-1375-995NAY Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-06-290

Event Narratives#

N

Patient 1

A FIELD SERVICE ENGINEER PERFORMED AN ON-SITE EVALUATION OF THE MEL80 EXCIMER LASER SYSTEM. THE REPORTED ERROR MESSAGE AND TERMINATION OF LASER PROCEDURE WERE DUE TO A FAILURE OF THE SHUTTER. AFTER REPLACEMENT OF THE DEFECTIVE SHUTTER THE DEVICE WAS CONFIRMED TO BE WORKING WITHIN SPECIFICATION. TERMINATION OF LASER PROCEDURE, IN THE EVENT OF SHUTTER FAILURE, IS AN INTENDED SYSTEM MONITORING FUNCTION OF THE MEL80. THE SHUTTER INTERRUPTS LASER EMISSION BY CLOSING TO PREVENT HUMAN EXPOSURE TO LASER RADIATION. THE TREATMENT CAN BE CONTINUED AT A LATER TIME. THE USER MANUAL (320817-0300-000-DOKS-FR-090117, 320817-0300-000-DOKS-GB-171212, PAGE 114) INSTRUCTS IN CASE OF SHUTTER ERROR, "CONFIRM THE MESSAGE. IF THIS ERROR REOCCURS, SWITCH OFF THE DEVICE AND CONTACT THE EXCIMER LASER HOTLINE".

D

Patient 1

THE HEALTH CARE PROFESSIONAL (HCP) REPORTED THE MEL80 EXCIMER LASER STOPPED AFTER 39% OF A REFRACTIVE SURGICAL PROCEDURE WAS COMPLETED. THE SYSTEM DISPLAYED ERROR #208, RELATED TO THE SHUTTER. THE HCP HAD TO ABORT THE PROCEDURE. NO ADVERSE CONSEQUENCES TO THE PATIENT WERE REPORTED.