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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO CORE 2 CONSOLE; DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE
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STRYKER INSTRUMENTS-KALAMAZOO CORE 2 CONSOLE; DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE Back to Search Results
Catalog Number 5400052000
Medical Device Problem Codes Unintended Power Up (1162); Unintended Movement (3026)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 03/26/2019
Type of Reportable Event Malfunction
Event or Problem Description
The user facility reported that the device ran over speed during a procedure.  there was no patient involvement, no delay, no medical intervention, and no adverse consequences.
 
Event or Problem Description
The user facility reported that the device ran over speed during a procedure.  there was no patient involvement, no delay, no medical intervention, and no adverse consequences.
 
Additional Manufacturer Narrative
Correction: d10, h3 additional info h6 h3 other text : device not returned.
 
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Brand Name
CORE 2 CONSOLE
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 Key8514929
Report Number0001811755-2019-01190
Device Sequence Number19300457
Product Code ERL
UDI-Device Identifier07613327298505
UDI-Public07613327298505
Combination Product (Y/N)N
Initial Reporter CountryFR
PMA/510(K) Number
K171840
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date (Section B) 01/13/2020
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 Health Professional
Device Catalogue Number5400052000
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 03/26/2019
Supplement Date Received by Manufacturer01/13/2020
Initial Report FDA Received Date04/15/2019
Supplement Report FDA Received Date01/13/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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