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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO TPS XL OSCILLIATING SAW UNIT, OPERATIVE DENTAL

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STRYKER INSTRUMENTS-KALAMAZOO TPS XL OSCILLIATING SAW UNIT, OPERATIVE DENTAL Back to Search Results
Catalog Number 5100131000
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/24/2019
Event Type  malfunction  
Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program. Reported events: 5 events were reported for this quarter. Product return status: 4 devices were received. 1 device was not available for evaluation. Event confirmation status: 4 reported events were confirmed. Evaluation results: 4 devices were found to be affected by a missing component. Additional information: 5 devices were not labeled for single-use. 5 devices were not reprocessed and reused.
 
Event Description
This report summarizes 5 malfunction events in which the device had a component detach. 5 events had no patient involvement; no patient impact.
 
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Brand NameTPS XL OSCILLIATING SAW
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 Key8816401
MDR Text Key152092057
Report Number0001811755-2019-02476
Device Sequence Number1
Product Code EIA
UDI-Device Identifier04546540983930
UDI-Public04546540983930
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported5
Summary Report (Y/N)Y
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial
Report Date 07/23/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/23/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number5100131000
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/24/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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