FLYTE HELMET 0408600000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2016-02-12 for FLYTE HELMET 0408600000 manufactured by Stryker Instruments-kalamazoo.

Event Text Entries

[38100111] It was reported that during a surgical procedure there was smoke coming out of the front nozzle of the device. The procedure was completed successfully without a surgical delay, and no adverse consequences or medical intervention.
Patient Sequence No: 1, Text Type: D, B5


[39015563] The device was not returned for analysis.
Patient Sequence No: 1, Text Type: N, H10


[39015564] It was reported that during a surgical procedure, there was smoke coming out of the front nozzle of the device. The procedure was completed successfully without a surgical delay, and no adverse consequences or medical intervention.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0001811755-2016-00191
MDR Report Key5433574
Report SourceUSER FACILITY
Date Received2016-02-12
Date of Report2016-01-19
Date of Event2016-01-18
Date Mfgr Received2016-01-19
Device Manufacturer Date2014-08-13
Date Added to Maude2016-02-12
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. CASEY METZGER
Manufacturer Street4100 EAST MILHAM AVENUE
Manufacturer CityKALAMAZOO MI 49001
Manufacturer CountryUS
Manufacturer Postal49001
Manufacturer Phone2693237700
Manufacturer G1STRYKER INSTRUMENTS-KALAMAZOO
Manufacturer Street4100 EAST MILHAM AVENUE
Manufacturer CityKALAMAZOO MI 49001
Manufacturer CountryUS
Manufacturer Postal Code49001
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameFLYTE HELMET
Generic NameHELMET, SURGICAL
Product CodeFXZ
Date Received2016-02-12
Catalog Number0408600000
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSTRYKER INSTRUMENTS-KALAMAZOO
Manufacturer Address4100 EAST MILHAM AVENUE KALAMAZOO MI 49001 US 49001


Patients

Patient NumberTreatmentOutcomeDate
10 2016-02-12

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