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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO TPS HANDPIECE CORD; UNIT, OPERATIVE DENTAL
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STRYKER INSTRUMENTS-KALAMAZOO TPS HANDPIECE CORD; UNIT, OPERATIVE DENTAL Back to Search Results
Catalog Number 5100004000
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/13/2015
Event Type  malfunction  
Event Description
It was reported that during a procedure at the user facility the cord caused the handpiece to run in reverse when it should have run in forward.The procedure was completed without a clinically significant delay, and no medical intervention or adverse consequences were reported.
 
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Brand Name
TPS HANDPIECE CORD
Type of Device
UNIT, 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 Key5278894
MDR Text Key33069628
Report Number0001811755-2015-04478
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
Type of Report Initial
Report Date 11/13/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/09/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number5100004000
Device Lot Number12292
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/19/2015
Date Manufacturer Received11/13/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/18/2012
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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