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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO 115 V AUTOPSY SAW SAW, POWERED, AND ACCESSORIES

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STRYKER INSTRUMENTS-KALAMAZOO 115 V AUTOPSY SAW SAW, POWERED, AND ACCESSORIES Back to Search Results
Catalog Number 0810000000
Device Problem Sparking (2595)
Patient Problem Not Applicable (3189)
Event Date 09/09/2016
Event Type  malfunction  
Event Description
It was reported that during an autopsy at the user facility that the device was sparking. The procedure was completed successfully and no adverse consequences were reported.
 
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Brand Name115 V AUTOPSY SAW
Type of DeviceSAW, POWERED, AND ACCESSORIES
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
Manufacturer Contact
casey metzger
4100 east milham avenue
kalamazoo, MI 49001
2693237700
MDR Report Key6010923
MDR Text Key56804625
Report Number0001811755-2016-02540
Device Sequence Number1
Product Code HAB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial
Report Date 09/09/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/07/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number0810000000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/05/2016
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/09/2016
Was Device Evaluated by Manufacturer? No
Date Device Manufactured05/12/2016
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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