NSE FOOTSWITCH 5400007000

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 2016-12-13 for NSE FOOTSWITCH 5400007000 manufactured by Stryker Instruments-kalamazoo.

Event Text Entries

[62270035] The user facility reported seeing exposed wires during setup prior to a procedure. The user facility reported that there were no surgical delay or adverse consequences related to this event.
Patient Sequence No: 1, Text Type: D, B5


[62831460] Added information from the investigation.
Patient Sequence No: 1, Text Type: N, H10


[62831461] The user facility reported seeing exposed wires during setup prior to a procedure. The user facility reported that there were no surgical delay or adverse consequences related to this event.
Patient Sequence No: 1, Text Type: D, B5


[62938743] Manufacturer report number 0001811755-2016-02840 was filed in error.? Additional information regarding the event clarified that the customer did not experience a reportable event per 21 cfr 803:20.
Patient Sequence No: 1, Text Type: N, H10


[62938744] The user facility reported seeing exposed wires during setup prior to a procedure. The user facility reported that there were no surgical delay or adverse consequences related to this event.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0001811755-2016-02840
MDR Report Key6171158
Report SourceUSER FACILITY
Date Received2016-12-13
Date of Report2016-12-20
Date of Event2016-11-03
Date Mfgr Received2016-12-20
Device Manufacturer Date2016-02-22
Date Added to Maude2016-12-13
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 NameNSE FOOTSWITCH
Generic NameDRIVER, WIRE, AND BONE DRILL, MANUAL
Product CodeDZJ
Date Received2016-12-13
Returned To Mfg2016-11-14
Catalog Number5400007000
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
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 2016-12-13

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