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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 Positioning Problem (3009)
Patient Problem No Patient Involvement (2645)
Event Date 06/05/2015
Event Type  malfunction  
Event Description
The universal handswitch was returned to stryker instruments for service.During functional testing by a service technician, it was found that the run/safe switch does not lock into either position, presenting a potential for the device to inadvertently be activated.No medical intervention and no adverse consequences were reported with this event.As this event occurred during testing at the manufacturer facility, there was no patient involvement and no delay to a surgical procedure.
 
Manufacturer Narrative
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 Key4882103
MDR Text Key6057412
Report Number0001811755-2015-02379
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
Report Date 06/05/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/01/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number5100009000
Device Lot Number11193
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/04/2015
Date Manufacturer Received06/05/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/12/2011
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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