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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO CORE POWERED INSTRUMENT DRIVER UNIT, OPERATIVE DENTAL

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STRYKER INSTRUMENTS-KALAMAZOO CORE POWERED INSTRUMENT DRIVER UNIT, OPERATIVE DENTAL Back to Search Results
Catalog Number 5400050000
Device Problem Overheating of Device (1437)
Patient Problem No Patient Involvement (2645)
Event Date 09/02/2017
Event Type  malfunction  
Manufacturer Narrative
This mdr report is part of the malfunction summary reporting program, exemption number e2015055. Supplemental rationale: corrected data: 3 previously reported events are included in this follow-up record.   product return status: 2 devices were received for evaluation. 1 device was not available to stryker for evaluation. Evaluation status: 2 events were not confirmed during testing; however: - 1 device was found to be affected by electrical interference. - 1 device was found to be affected by a faulty handpiece interface connector. Additional information: 3 devices were not labeled for single-use. 3 devices were not reprocessed and reused.
 
Event Description
This report summarizes 4 malfunction events in which the device reportedly overheated. 4 events had no patient involvement; no patient impact.
 
Manufacturer Narrative
This mdr report is part of the malfunction summary reporting program, exemption number (b)(4). 4 events were reported for this quarter. 3 devices were received. The reported event was not confirmed for 1 device; the device was found to be within specifications for the reported event. 2 device evaluations are in progress. 1 device was available for evaluation but has not yet been received. There were no remedial actions taken. This device is not labeled for single-use.
 
Event Description
This report summarizes 4 malfunction events in which the device reportedly overheated. 2 events had no patient involvement; no patient impact. 2 events had no known patient involvement; no known patient impact; attempts are being made for additional information.
 
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Brand NameCORE POWERED INSTRUMENT DRIVER
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 Key7219521
MDR Text Key182238714
Report Number0001811755-2018-00175
Device Sequence Number1
Product Code EIA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported4
Summary Report (Y/N)Y
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/24/2018
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 Number5400050000
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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