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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 Material Fragmentation (1261)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/02/2018
Event Type  malfunction  
Manufacturer Narrative
This mdr is part of the malfunction summary reporting program, exemption number e2015055. Reported events: 3 events were reported for this quarter. Product return status: 3 devices were received for evaluation. Evaluation status: 3 events were confirmed during testing, 3 devices were found to be affected by part of the bottom lever missing. Product disposition: these devices are not repairable and were not returned to the user facility. Additional information, there were no remedial actions taken on this device. This device is not labeled for single-use.
 
Event Description
This report summarizes 3 malfunction events in which the device had small pieces breaking off. 3 events had no 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
zach baker
4100 east milham avenue
kalamazoo, MI 49001
2693237700
MDR Report Key7714812
MDR Text Key115215408
Report Number0001811755-2018-01206
Device Sequence Number1
Product Code EIA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported3
Summary Report (Y/N)Y
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial
Report Date 07/24/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/24/2018
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number5100009000
Device Lot NumberE2015055
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/02/2018
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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