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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO CAST CUTTER SAW, POWERED, AND ACCESSORIES

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STRYKER INSTRUMENTS-KALAMAZOO CAST CUTTER SAW, POWERED, AND ACCESSORIES Back to Search Results
Catalog Number 0940000000
Device Problem Device Remains Activated (1525)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/01/2017
Event Type  malfunction  
Event Description
It was reported at the user facility that the device would continue to run after it was turned off. Although requested, no information was available regarding patient involvement, adverse consequences, surgical delay or medical intervention.
 
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Brand NameCAST CUTTER
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 Key6676300
MDR Text Key78666931
Report Number0001811755-2017-01353
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
Type of Report Initial
Report Date 06/29/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/29/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number0940000000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/06/2017
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/01/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/10/1997
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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