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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO CAST CUTTER 230 V SAW, POWERED, AND ACCESSORIES

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STRYKER INSTRUMENTS-KALAMAZOO CAST CUTTER 230 V SAW, POWERED, AND ACCESSORIES Back to Search Results
Catalog Number 0941000000
Device Problem Insufficient Information (3190)
Patient Problem Abrasion (1689)
Event Date 01/11/2018
Event Type  Injury  
Manufacturer Narrative
Supplemental submitted to document device evaluation results.
 
Event Description
It was reported at the user facility that the device cut a patient during a procedure. Although requested no further information was provided.
 
Manufacturer Narrative
The device is available for return. A follow up report will be filed once the quality investigation is complete.
 
Event Description
It was reported at the user facility that the device cut a patient during a procedure. No further information was provided.
 
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Brand NameCAST CUTTER 230 V
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
zach baker
4100 east milham avenue
kalamazoo, MI 49001
2693237700
MDR Report Key7258833
MDR Text Key113528867
Report Number0001811755-2018-00398
Device Sequence Number1
Product Code HAB
Combination Product (y/n)N
Reporter Country CodeNO
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/25/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/09/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number0941000000
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/11/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/10/2014
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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