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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
Model Number 5400052000
Medical Device Problem Code Unintended Power Up (1162)
Health Effect - Clinical Codes No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Date of Event 12/12/2019
Type of Reportable Event Malfunction
Event or Problem Description
The user facility reported that the device caused unintended activation during testing prior to a procedure.  there was no patient impact, no delay, no medical intervention, and no adverse consequences.
 
Additional Manufacturer Narrative
Customer declined return.
 
Event or Problem Description
The user facility reported that the device caused unintended activation during testing prior to a procedure.  there was no patient impact, no delay, no medical intervention, and no adverse consequences.
 
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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 Key9596027
Report Number0001811755-2020-00055
Device Sequence Number3174946
Product Code ERL
UDI-Device Identifier07613327298505
UDI-Public07613327298505
Combination Product (Y/N)N
Initial Reporter CountryHK
PMA/510(K) Number
K171840
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source user facility
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 03/09/2020
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 Model Number5400052000
Device Catalogue Number5400052000
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 12/19/2019
Supplement Date Received by Manufacturer03/06/2020
Initial Report FDA Received Date01/16/2020
Supplement Report FDA Received Date03/09/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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