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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO LOANER MAESTRO HANDSWITCH; MOTOR, DRILL, PNEUMATIC
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STRYKER INSTRUMENTS-KALAMAZOO LOANER MAESTRO HANDSWITCH; MOTOR, DRILL, PNEUMATIC Back to Search Results
Catalog Number 5400201000L
Device Problem Unintended Power Up (1162)
Patient Problem No Patient Involvement (2645)
Event Date 08/11/2015
Event Type  malfunction  
Event Description
It was reported that during testing conducted at the manufacturer facility, the device ran without user activation.As this occurred during testing at the manufacturer facility, no patient involvement, no delay, no medical intervention and no adverse consequences were reported with this event, and there was no associated procedure.
 
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Brand Name
LOANER MAESTRO HANDSWITCH
Type of Device
MOTOR, DRILL, PNEUMATIC
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 Key5045532
MDR Text Key24691876
Report Number0001811755-2015-03176
Device Sequence Number1
Product Code HBB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K041754
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other
Report Date 08/11/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/01/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number5400201000L
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/07/2015
Was the Report Sent to FDA? No
Date Manufacturer Received08/11/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/15/2007
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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