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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 10/31/2015
Event Type  malfunction  
Event Description
It was reported that during routine maintenance conducted by a manufacturer field service technician at the user facility, the run/safe switch on the handswitch does not lock into either position, presenting a potential for the device to inadvertently be activated.As this event occurred during testing at the user facility, there was no patient involvement, no delay, no medical intervention, and no adverse consequences.
 
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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 Key5246277
MDR Text Key32016097
Report Number0001811755-2015-04284
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 10/31/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/24/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number5100009000
Device Lot Number09187
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/03/2015
Date Manufacturer Received10/31/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/06/2009
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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