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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO MASK COMMUNICATION UNIT FOR ENT AUTOREGISTRATION MASK; NEUROLOGICAL STEREOTAXIC INSTRUMENT
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STRYKER INSTRUMENTS-KALAMAZOO MASK COMMUNICATION UNIT FOR ENT AUTOREGISTRATION MASK; NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number 6001-380-000
Device Problems Bent (1059); Break (1069)
Patient Problem Therapeutic Effects, Unexpected (2099)
Event Date 10/15/2014
Event Type  Injury  
Event Description
During an endoscopic sinus surgery, the prongs of the mask communication unit for ent autoregistration mask were found to be bent and broken.Navigation was aborted, and the procedure was completed successfully using conventional methods.There was a procedural delay of 30 minutes, requiring administration of additional anesthesia to the patient.No adverse consequences were reported with this event.
 
Event Description
During an endoscopic sinus surgery, the prongs of the mask communication unit for ent autoregistration mask were found to be bent and broken.Navigation was aborted, and the procedure was completed successfully using conventional methods.There was a procedural delay of 30 minutes, requiring administration of additional anesthesia to the patient.No adverse consequences were reported with this event.
 
Manufacturer Narrative
During the device evaluation, the reported event could be confirmed, however, the root cause of the broken pins could not be determined.
 
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Brand Name
MASK COMMUNICATION UNIT FOR ENT AUTOREGISTRATION MASK
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-79 111
Manufacturer Contact
casey metzger
4100 east milham avenue
kalamazoo, MI 49001
2693237700
MDR Report Key4247873
MDR Text Key15113247
Report Number0001811755-2014-04095
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 User Facility
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 10/16/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/13/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number6001-380-000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/12/2014
Is the Reporter a Health Professional? No
Date Manufacturer Received01/13/2015
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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