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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 Overheating of Device (1437)
Patient Problem Abrasion (1689)
Event Date 03/17/2017
Event Type  malfunction  
Manufacturer Narrative
The reported event was not duplicated.
 
Event Description
It was reported that during a procedure at the user facility that the device became warm during use. The patient reported red marks as a result of the device warming up; however, the customer verified that the patient did not receive medical treatment as a result of the event and, while there were red marks on the patient, there was no medically diagnosed burn. No medical intervention was administered as a result of the event.
 
Event Description
It was reported that during a procedure at the user facility that the device became warm during use. The patient reported red marks as a result of the device warming up; however, the customer verified that the patient did not receive medical treatment as a result of the event and, while there were red marks on the patient, there was no medically diagnosed burn. No medical intervention was administered as a result of the event.
 
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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
zachary baker
4100 east milham avenue
kalamazoo, MI 49001
2693237700
MDR Report Key6536346
MDR Text Key159871257
Report Number0001811755-2017-01209
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,Followup
Report Date 03/13/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/02/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number0940000000
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/20/2018
Was Device Evaluated by Manufacturer? No
Date Device Manufactured01/14/2011
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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