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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 Problems Device Operates Differently Than Expected (2913); Failure to Shut Off (2939)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/02/2015
Event Type  malfunction  
Event Description
It was reported that during a procedure at the user facility, the cord caused the handpiece to continue run when in the "off" position.The procedure was completed successfully with no delay, no medical intervention, and no adverse consequences 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 Key5322819
MDR Text Key34919564
Report Number0001811755-2015-04745
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 12/04/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/23/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number5100004000
Device Lot Number11318
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/09/2015
Date Manufacturer Received12/04/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/14/2011
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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