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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO TPS FOOTSWITCH IPX7 UNIT, OPERATIVE DENTAL
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STRYKER INSTRUMENTS-KALAMAZOO TPS FOOTSWITCH IPX7 UNIT, OPERATIVE DENTAL Back to Search Results
Catalog Number 5100008000
Device Problem Device Remains Activated (1525)
Patient Problem No Patient Involvement (2645)
Event Date 12/02/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). One event was reported for this quarter. One device was received for evaluation. One device evaluation is in progress. There were no remedial actions taken. This device is not labeled for single-use.
 
Event Description
This report summarizes 1 malfunction event in which the device ran without user activation. One event had no known patient involvement or patient impact.
 
Manufacturer Narrative
This mdr report is part of the malfunction summary reporting program, exemption number e2015055.     supplemental rationale corrected data: 1 previously reported events are included in this follow-up record. Evaluation status 1 reported event was not confirmed during testing; the cause was not established.   additional information 1 device is not labeled for single-use. 1 device was not reprocessed and reused.
 
Event Description
This report summarizes 1 malfunction event in which the device ran without user activation. 1 event had no known patient involvement or patient impact.
 
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Brand NameTPS FOOTSWITCH IPX7
Type of DeviceUNIT, OPERATIVE DENTAL
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key7466777
Report Number0001811755-2018-00718
Device Sequence Number1
Product Code EIA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)Y
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 10/29/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/26/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number5100008000
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/02/2017
Is This a Reprocessed and Reused Single-Use Device? No
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