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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO FOOTSWITCH; UNIT, OPERATIVE DENTAL
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STRYKER INSTRUMENTS-KALAMAZOO FOOTSWITCH; UNIT, OPERATIVE DENTAL Back to Search Results
Model Number 5100008000
Medical Device Problem Code Unintended Power Up (1162)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 12/31/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Reported events: 1 previously reported event was included under mfr report # 0001811755-2020-00227 but should be included under this report.Product return status: 1 device was received.Event confirmation status: 1 reported event was not confirmed.Evaluation results: 1 device was found to be affected by a damaged cable.
 
Event or Problem Description
This report summarizes 1 malfunction event in which the device ran without user activation.1 event had no patient involvement; no patient impact.
 
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Brand Name
FOOTSWITCH
Common Device Name
UNIT, OPERATIVE DENTAL
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key10011402
Report Number0001811755-2020-01239
Device Sequence Number11448123
Product Code EIA
UDI-Device Identifier04546540971272
UDI-Public04546540971272
Combination Product (Y/N)N
Initial Reporter StateMI
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)Y
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 04/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device No Information
Device Model Number5100008000
Device Catalogue Number5100008000
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 12/31/2019
Initial Report FDA Received Date04/29/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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