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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO AUTOPSY SAW 115V; SAW, POWERED, AND ACCESSORIES
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STRYKER INSTRUMENTS-KALAMAZOO AUTOPSY SAW 115V; SAW, POWERED, AND ACCESSORIES Back to Search Results
Catalog Number 0810000000
Device Problem Sparking (2595)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/29/2014
Event Type  malfunction  
Event Description
It was reported that the autopsy saw was sparking during a procedure at the user facility.The procedure was completed successfully.No delay, no medical intervention and no adverse consequences were reported with this event.
 
Manufacturer Narrative
The device has been received, but the evaluation has not yet begun.Additional information may be submitted once the quality investigation is complete.
 
Event Description
It was reported that the autopsy saw was sparking during a procedure at the user facility.The procedure was completed successfully.No delay, no medical intervention and no adverse consequences were reported with this event.
 
Manufacturer Narrative
The reported event, saw is sparking was duplicated.Through functional and visual inspection, the technician confirmed sparking internally and the saw was not able to reach full speed.Upon disassembled, a short in the coil was found.The device is not repairable and moved to parts retention.
 
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Brand Name
AUTOPSY SAW 115V
Type of Device
SAW, 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 Key3893873
MDR Text Key4647548
Report Number0001811755-2014-02264
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 User Facility
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 05/29/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
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 Manufacturer06/10/2014
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 07/23/2014
Initial Date FDA Received06/25/2014
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received07/25/2014
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
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