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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 Problems Bent (1059); Disassembly (1168)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/18/2016
Event Type  malfunction  
Event Description
It was reported that the tip of the pointer was identified to be broken off while at the user facility. Although requested, the user facility was not able to provide further details regarding patient involvement, adverse consequences or procedural delays.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the tip of the pointer was identified to be bent while at the user facility. Although requested, the user facility was not able to provide further details regarding patient involvement, adverse consequences or procedural delays.
 
Manufacturer Narrative
Additional information: the reported event that the tip of the device was not broken off, but had been bent was confirmed through the device inspection. Any physical impact to the navigated instrument can cause product damage or operational failure due to battery movement.
 
Event Description
It was reported that the tip of the pointer was identified to be bent while at the user facility. Although requested, the user facility was not able to provide further details regarding patient involvement, adverse consequences or procedural delays.
 
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Brand NameLARGE POINTER
Type of DeviceNEUROLOGICAL STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
Manufacturer (Section G)
STRYKER INSTRUMENTS-FREIBURG
boetzingerstr. 41
freiburg D-791 11
Manufacturer Contact
casey metzger
4100 east milham avenue
kalamazoo, MI 49001
2693237700
MDR Report Key6180884
MDR Text Key62679470
Report Number0001811755-2016-02857
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
Type of Report Initial,Followup,Followup
Report Date 02/09/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/16/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number6000-011-000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/29/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/30/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/04/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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