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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO UNIVERSAL HANDSWITCH; UNIT, OPERATIVE DENTAL
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STRYKER INSTRUMENTS-KALAMAZOO UNIVERSAL HANDSWITCH; UNIT, OPERATIVE DENTAL Back to Search Results
Catalog Number 5100009000
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Patient Involvement (2645)
Event Date 03/18/2015
Event Type  malfunction  
Event Description
It was reported that the run/safe switch would not lock into either position during a routine equipment evaluation at the user facility, by a manufacturers' service technician.The run/safe switch not locking into either position creates a situation from which the device may be unintentionally activated.There was no patient involvement, and there were no user injuries or adverse consequences.
 
Event Description
It was reported that the run/safe switch would not lock into either position during a routine equipment evaluation at the user facility, by a manufacturers' service technician.The run/safe switch not locking into either position creates a situation from which the device may be unintentionally activated.There was no patient involvement, and there were no user injuries or adverse consequences.
 
Manufacturer Narrative
A follow up report will be filed after the quality investigation has been completed.
 
Manufacturer Narrative
Age is known to cause or contribute to the reported event.The handswitch is not a repairable device and will not be returned to the user facility.
 
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Brand Name
UNIVERSAL HANDSWITCH
Type of Device
UNIT, OPERATIVE DENTAL
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 Key4694055
MDR Text Key5713606
Report Number0001811755-2015-01393
Device Sequence Number1
Product Code EIA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K032117
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 03/18/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/15/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number5100009000
Device Lot Number07259
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/20/2015
Is the Reporter a Health Professional? No
Date Manufacturer Received05/20/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/16/2007
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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