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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO TPS UNIVERSAL HANDSWITCH UNIT, OPERATIVE DENTAL

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STRYKER INSTRUMENTS-KALAMAZOO TPS UNIVERSAL HANDSWITCH UNIT, OPERATIVE DENTAL Back to Search Results
Catalog Number 5100009000
Device Problem Device Remains Activated (1525)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/01/2016
Event Type  malfunction  
Manufacturer Narrative
This mdr report is part of the malfunction summary reporting program, exemption number (b)(4). The reported device was received for evaluation; event was not confirmed during testing. No component failures were observed. This is not a repairable device and therefore it was not returned to the user facility. There were no remedial actions taken on this device. This device is not labeled for single-use.
 
Event Description
This report summarizes 1 malfunction event in which the device continued to run when in safe mode. There was patient involvement; no patient impact.
 
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Brand NameTPS UNIVERSAL HANDSWITCH
Type of DeviceUNIT, 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 Key6280102
MDR Text Key66045023
Report Number0001811755-2017-00277
Device Sequence Number1
Product Code EIA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)Y
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial
Report Date 01/26/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/26/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number5100009000
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/01/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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