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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO INSTRUMENT BATTERY; NEUROLOGICAL STEREOTAXIC INSTRUMENT
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STRYKER INSTRUMENTS-KALAMAZOO INSTRUMENT BATTERY; NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 6000-006-000
Medical Device Problem Code Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 10/31/2017
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that at inspection at the user facility a foreign particle was found in the sterile packaging of the instruments battery.No patient involvement, no delay, no medical intervention and no adverse consequences were reported with this event.
 
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Brand Name
INSTRUMENT BATTERY
Common Device Name
NEUROLOGICAL STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key7048122
Report Number0001811755-2017-02366
Device Sequence Number13732793
Product Code HAW
UDI-Device Identifier04546540245045
UDI-Public(01)04546540245045
Combination Product (Y/N)N
Initial Reporter StateLA
Initial Reporter CountryUS
PMA/510(K) Number
K993239
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source user facility
Initial Reporter Occupation Nurse
Type of Report Initial
Report Date (Section B) 11/21/2017
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 Number6000-006-000
Device Catalogue Number6000006000
Device Lot Number2017021284
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/01/2017
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/31/2017
Initial Report FDA Received Date11/21/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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