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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 Consequences Or Impact To Patient (2199)
Event Date 12/02/2017
Event Type  malfunction  
Manufacturer Narrative
This mdr report is part of the malfunction summary reporting program, exemption number (b)(4). 2 events were reported for this quarter. 1 devices were received for evaluation. 1 device was available for evaluation but has not yet been received.                  1 event was confirmed during testing. 1 device was found to be affected by a deformed boot. 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 2 malfunction events in which the device had run-on. 1 event had no patient involvement; no patient impact. 1 event had 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
zach baker
4100 east milham avenue
kalamazoo, MI 49001
2693237700
MDR Report Key7466775
MDR Text Key106861649
Report Number0001811755-2018-00717
Device Sequence Number1
Product Code EIA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported2
Summary Report (Y/N)Y
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/29/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/26/2018
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? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/02/2017
Was Device Evaluated by Manufacturer? No
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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