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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO SEEKER, RH FRONTAL SINUS; NEUROLOGICAL STEREOTAXIC INSTRUMENT
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STRYKER INSTRUMENTS-KALAMAZOO SEEKER, RH FRONTAL SINUS; NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number 6001-032-000
Device Problem Degraded (1153)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/06/2017
Event Type  malfunction  
Event Description
It was reported that the tip of the device was found to be flattened.There was no known patient impact or procedural delays associated with the event.
 
Manufacturer Narrative
Device evaluation: follow-up report submitted to document device evaluation results.
 
Event Description
It was reported that the tip of the device was found to be flattened.There was no known patient impact or procedural delays associated with the event.
 
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Brand Name
SEEKER, RH FRONTAL SINUS
Type of Device
NEUROLOGICAL 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
zachary baker
4100 east milham avenue
kalamazoo, MI 49001
2693237700
MDR Report Key7075639
MDR Text Key93497994
Report Number0001811755-2017-02392
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K002732
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/16/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/01/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number6001-032-000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/13/2017
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/05/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/18/2010
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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