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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
Medical Device Problem Code Material Fragmentation (1261)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 03/02/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
This mdr report 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 or Problem 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 Name
TPS UNIVERSAL HANDSWITCH
Common Device Name
UNIT, OPERATIVE DENTAL
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key7714812
Report Number0001811755-2018-01206
Device Sequence Number995770
Product Code EIA
UDI-Device Identifier04546540074393
UDI-Public04546540074393
Combination Product (Y/N)N
Initial Reporter StateMI
Initial Reporter CountryUS
Number of Events Summarized3
Summary Report (Y/N)Y
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 07/24/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Operator of Device No Information
Device Catalogue Number5100009000
Device Lot NumberE2015055
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/02/2018
Initial Report FDA Received Date07/24/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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