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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 Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 04/21/2020
Type of Reportable Event Malfunction
Event or Problem Description
The user facility reported that the device is causing handpieces to rotate during on its own during testing prior to a procedure.  there was no patient involvement, no delay, no medical intervention, and no adverse consequences.
 
Additional Manufacturer Narrative
Additional information: d10 device evaluation: follow-up report submitted to document device evaluation results.
 
Event or Problem Description
The user facility reported that the device is causing handpieces to rotate during on its own during testing prior to a procedure.  there was no patient involvement, 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 Key10065090
Report Number0001811755-2020-01284
Device Sequence Number10956599
Product Code ERL
UDI-Device Identifier07613327298505
UDI-Public07613327298505
Combination Product (Y/N)N
Initial Reporter CountryTW
PMA/510(K) Number
K112593
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date (Section B) 01/04/2021
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? Device Returned to Manufacturer
Date Returned to Manufacturer07/20/2020
Initial Date Received by Manufacturer 04/21/2020
Supplement Date Received by Manufacturer01/04/2021
Initial Report FDA Received Date05/18/2020
Supplement Report FDA Received Date01/04/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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