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U.S. Department of Health and Human Services

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

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STRYKER INSTRUMENTS-KALAMAZOO TPS CORD UNIT, OPERATIVE DENTAL Back to Search Results
Catalog Number 5100004000
Device Problem Overheating of Device (1437)
Patient Problem No Patient Involvement (2645)
Event Date 03/02/2018
Event Type  malfunction  
Manufacturer Narrative
This mdr report is part of the malfunction summary reporting program, exemption number (b)(4). Reported events; 2 events were reported for this quarter. Product return status; 1 device was received for evaluation. One device was available for evaluation but has not yet been received. Evaluation status; 1 event was not confirmed during testing. One event was confirmed during testing. -one device was found to be affected by an electrical issue. Product disposition: this device is not repairable and was not returned to the user facility. Additional information: 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 reportedly overheated. Two events had no patient involvement; no patient impact.
 
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Brand NameTPS CORD
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 Key7714798
MDR Text Key115213927
Report Number0001811755-2018-01203
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 01/31/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/24/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number5100004000
Device Lot NumberE2015055
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 Received03/02/2018
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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