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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 Electrical /Electronic Property Problem (1198)
Patient Problem Shock (2072)
Event Date 04/17/2015
Event Type  malfunction  
Event Description
It was reported that during use at the user facility, the user received an electric shock from the device.No patient involvement, no delay, no medical intervention, and no adverse consequences were reported with this event.
 
Manufacturer Narrative
Failure analysis is in progress; additional information will be submitted once the quality investigation is completed.
 
Event Description
It was reported that during use at the user facility, the user received an electric shock from the device.No patient involvement, no delay, no medical intervention, and no adverse consequences were reported with this event.
 
Manufacturer Narrative
The reported event of shocking was not confirmed.Service evaluation did not produce shocking symptoms, but did observe intermittent power.No frayed or cut wires were observed.The device was repaired and returned to the customer.
 
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Brand Name
CAST CUTTER
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 Key4769397
MDR Text Key5778231
Report Number0001811755-2015-01742
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 04/17/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/13/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number0940000000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/28/2015
Is the Reporter a Health Professional? No
Date Manufacturer Received07/17/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/31/2011
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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