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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 No Patient Involvement (2645)
Event Date 12/01/2017
Event Type  Malfunction  
Event Description

It was reported during setup at the user facility that the device would spark. There was no patient involvement, no delay, no medical intervention, and no adverse consequences.

 
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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
zachary baker
4100 east milham avenue
kalamazoo, MI 49001
2693237700
MDR Report Key7150572
MDR Text Key95926172
Report Number0001811755-2017-02502
Device Sequence Number1
Product Code HAB
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberEXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type USER FACILITY
Reporter Occupation
Type of Report Initial
Report Date 12/28/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/28/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number0810000000
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/05/2017
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/01/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/08/2017
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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