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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 11/30/2017
Event Type  Malfunction  
Event Description

It was reported during a procedure 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 Key7150730
MDR Text Key95925984
Report Number0001811755-2017-02505
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 NO INFORMATION
Device Catalogue Number0810000000
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/17/2017
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/04/2017
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

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