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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO LARGE POINTER; NEUROLOGICAL STEREOTAXIC INSTRUMENT

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STRYKER INSTRUMENTS-KALAMAZOO LARGE POINTER; NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number 6000-011-000
Device Problem Bent (1059)
Patient Problem No Patient Involvement (2645)
Event Date 12/18/2013
Event Type  malfunction  
Event Description
It was reported that the tip of the large pointer was bent during testing in the sterile processing department.There was no patient involvement and no adverse consequences associated with the device.
 
Event Description
It was reported that the tip of the large pointer was bent during testing in the sterile processing department.There was no patient involvement and no adverse consequences associated with the device.
 
Manufacturer Narrative
Device not yet returned for investigation.
 
Manufacturer Narrative
The reported event that the pointer tip was bent was duplicated; it was confirmed during visual inspection that the device had a bent tip as well as during the functional inspection with the production software.It is possible that bending forces caused the reported event.The pointer is not a repairable device and will not be returned to the user facility.
 
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Brand Name
LARGE POINTER
Type of Device
NEUROLOGICAL STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
Manufacturer (Section G)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001 D-7
Manufacturer Contact
casey metzger
4100 east milham avenue
kalamazoo, MI 49001
2693237700
MDR Report Key3571755
MDR Text Key4218935
Report Number0001811755-2014-00126
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K993239
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 12/18/2013
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
Device Operator Health Professional
Device Catalogue Number6000-011-000
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 02/25/2014
Initial Date FDA Received01/13/2014
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received03/11/2014
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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