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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO TPS UNIDIRECTIONAL FOOTSWITCH; OPERATIVE DENTAL
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STRYKER INSTRUMENTS-KALAMAZOO TPS UNIDIRECTIONAL FOOTSWITCH; OPERATIVE DENTAL Back to Search Results
Catalog Number 5100007000
Device Problem Mechanical Problem (1384)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/01/2015
Event Type  malfunction  
Event Description
It was reported that during a procedure at the user facility the device was continuing to run on.The procedure was completed successfully with no delay, no medical intervention, and no adverse consequences reported.
 
Manufacturer Narrative
The technician was unable to duplicate the sticking pedal (run-on) with use of shop console.However, based on disassembly by a diagnostic engineer, visual inspection confirmed that the pedal was hitting the potting.Since this product is not a repairable item, it was disposed of by the manufacturer facility and not returned to the healthcare facility.
 
Event Description
It was reported that during a procedure at the user facility the device was continuing to run on.The procedure was completed successfully with no delay, no medical intervention, and no adverse consequences reported.
 
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Brand Name
TPS UNIDIRECTIONAL FOOTSWITCH
Type of Device
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
casey metzger
4100 east milham avenue
kalamazoo, MI 49001
2693237700
MDR Report Key5181364
MDR Text Key29969594
Report Number0001811755-2015-03929
Device Sequence Number1
Product Code EIA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K032117
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 10/01/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/27/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number5100007000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/08/2015
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/14/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/05/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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