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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO CORE U-HT HANDSWITCH; DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE
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STRYKER INSTRUMENTS-KALAMAZOO CORE U-HT HANDSWITCH; DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE Back to Search Results
Model Number 5400111000
Medical Device Problem Codes Overheating of Device (1437); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 03/01/2019
Type of Reportable Event Malfunction
Event or Problem Description
The manufacturer service technician reported that the device overheated while it was being serviced at the user facility.There were no adverse consequences related to this event.
 
Additional Manufacturer Narrative
The device was not returned for evaluation; therefore, a root cause could not be determined for the event.Device not returned.
 
Event or Problem Description
The manufacturer service technician reported that the device overheated while it was being serviced at the user facility.There were no adverse consequences related to this event.
 
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Brand Name
CORE U-HT HANDSWITCH
Common Device Name
DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key8409555
Report Number0001811755-2019-00808
Device Sequence Number420489
Product Code ERL
UDI-Device Identifier04546540402004
UDI-Public04546540402004
Combination Product (Y/N)N
Initial Reporter StateND
Initial Reporter CountryUS
PMA/510(K) Number
K112593
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 04/01/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Other
Device Model Number5400111000
Device Catalogue Number5400111000
Device Lot Number11027
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 03/01/2019
Supplement Date Received by Manufacturer03/31/2020
Initial Report FDA Received Date03/11/2019
Supplement Report FDA Received Date04/01/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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