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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 Mechanical Problem (1384)
Patient Problem No Patient Involvement (2645)
Event Date 01/20/2015
Event Type  malfunction  
Event Description
The universal handswitch was returned for service.Upon evaluation at the manufacturer, it was discovered that the run/safe switch moves freely creating a situation from which the device may be activated unintentionally.There was no patient involvement, and there were no user injuries or adverse consequences.
 
Manufacturer Narrative
The reported event was confirmed, the run/safe switch moved freely and the run/safe etchings were found to be worn, but still legible.Based on a review of the risk documents, an impact damage may cause or contribute to the reported event of the run/safe moving freely.The worn run/safe etchings were likely a result of the cleaning process.The device was scrapped by the manufacturer.
 
Event Description
The universal handswitch was returned for service.Upon evaluation at the manufacturer, it was discovered that the run/safe switch moves freely creating a situation from which the device may be activated unintentionally.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.
 
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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 Key4520901
MDR Text Key5746047
Report Number0001811755-2015-00544
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 01/20/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/17/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number5100009000
Device Lot Number10011
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/19/2015
Is the Reporter a Health Professional? No
Date Manufacturer Received03/24/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/11/2010
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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