ESSX HANDPIECE 5290601200

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 2020-03-30 for ESSX HANDPIECE 5290601200 manufactured by Stryker Instruments-kalamazoo.

Event Text Entries

[187899390] During service at the manufacturer it was noted the actuation valve assembly was missing. There was no patient involvement reported with this event.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0001811755-2020-00799
MDR Report Key9897722
Report SourceCOMPANY REPRESENTATIVE
Date Received2020-03-30
Date of Report2020-03-30
Date of Event2020-03-04
Date Mfgr Received2020-03-04
Device Manufacturer Date2014-06-24
Date Added to Maude2020-03-30
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. ZACH BAKER
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 NameESSX HANDPIECE
Generic NameDRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE
Product CodeERL
Date Received2020-03-30
Returned To Mfg2019-12-20
Model Number5290601200
Catalog Number5290601200
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerSTRYKER INSTRUMENTS-KALAMAZOO
Manufacturer Address4100 EAST MILHAM AVENUE KALAMAZOO MI 49001 US 49001


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-30

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