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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO TPS UNIDIRECTIONAL FOOTSWITCH UNIT, OPERATIVE DENTAL

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STRYKER INSTRUMENTS-KALAMAZOO TPS UNIDIRECTIONAL FOOTSWITCH UNIT, OPERATIVE DENTAL Back to Search Results
Catalog Number 5100007000
Device Problem Device Remains Activated (1525)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/02/2017
Event Type  malfunction  
Manufacturer Narrative
This mdr report is part of the malfunction summary reporting program, exemption number (b)(4). Five events were reported for this quarter. (b)(4) devices were received for evaluation. Four events were confirmed. (b)(4) devices were found to be affected by damaged components. (b)(4) devices were found to be affected by a migrated component. The reported event was not confirmed for 1 device; the device was found to be within specifications for the reported event. This device is not repairable and was not returned to the user facility. There were no remedial actions taken. This device is not labeled for single-use.
 
Event Description
This report summarizes 5 malfunction events in which the device had run-on. Five reported events had no patient involvement; no patient impact.
 
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Brand NameTPS UNIDIRECTIONAL FOOTSWITCH
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
zachary baker
4100 east milham avenue
kalamazoo, MI 49001
2693237700
MDR Report Key7219259
MDR Text Key98435405
Report Number0001811755-2018-00093
Device Sequence Number1
Product Code EIA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported5
Summary Report (Y/N)Y
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial
Report Date 01/25/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/25/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number5100007000
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/02/2017
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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