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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 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. 1 device was received. The reported event was not duplicated during testing for 1 device; however, the device was outside specifications. 1 device was found to be affected by an electrical problem. 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 reportedly overheated. 1 event had no patient involvement; no patient impact. 1 event had patient involvement; no patient impact.
 
Manufacturer Narrative
This mdr report is part of the malfunction summary reporting program, exemption number (b)(4). Two (2) events were reported for this quarter. Two (2) devices were received. One (1) device was not able to be evaluated for the reported event as there was a short in the device. One (1) device evaluation is in progress. 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 two (2) malfunction events in which the device reportedly overheated. One (1) event had no patient involvement; no patient impact. One (1) event had 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
zachary baker
4100 east milham avenue
kalamazoo, MI 49001
2693237700
MDR Report Key7219272
MDR Text Key159685799
Report Number0001811755-2018-00096
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 03/02/2018
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 Number5100004000
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 Received09/02/2017
Was Device Evaluated by Manufacturer? Yes
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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