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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO AWL; NEUROLOGICAL STEREOTAXIC INSTRUMENT
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STRYKER INSTRUMENTS-KALAMAZOO AWL; NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number 6002-700-000
Device Problem Image Display Error/Artifact (1304)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/29/2019
Event Type  malfunction  
Event Description
It was reported that during testing conducted at the user facility prior to the start of a surgical procedure the device was unable to display accurate depth. the procedure was completed successfully without a clinically significant delay; no adverse consequences or medical intervention were reported.
 
Manufacturer Narrative
Device evaluation: follow-up report submitted to document device evaluation results.
 
Event Description
It was reported that during testing conducted at the user facility prior to the start of a surgical procedure the device was unable to display accurate depth. the procedure was completed successfully without a clinically significant delay; no adverse consequences or medical intervention were reported.
 
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Brand Name
AWL
Type of Device
NEUROLOGICAL STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key8544465
MDR Text Key142906903
Report Number0001811755-2019-01300
Device Sequence Number1
Product Code HAW
UDI-Device Identifier04546540387448
UDI-Public04546540387448
Combination Product (y/n)N
PMA/PMN Number
K993239
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 06/03/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/24/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number6002-700-000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/07/2019
Date Manufacturer Received06/03/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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