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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO CASTVAC W/8 FOOT HOSE AND MOBILE STAND; SAW, POWERED, AND ACCESSORIES
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STRYKER INSTRUMENTS-KALAMAZOO CASTVAC W/8 FOOT HOSE AND MOBILE STAND; SAW, POWERED, AND ACCESSORIES Back to Search Results
Catalog Number 0986000000
Device Problem Sparking (2595)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/01/2014
Event Type  malfunction  
Event Description
It was reported that the cast vacuum motor is sparking during a cast removal procedure at user facility.The procedure was completed successfully.No delay, no medical intervention and no adverse consequences were reported with this event.
 
Manufacturer Narrative
The reported event, it was throwing sparks, was duplicated.Through inspection, the service technician noted that the castvac was sparking and making noise due to a motor failure.Upon disassembly, the technician noted that the castvac was full of dust suffocating the motor.The motor was replaced along with other preventative maintenance returned to the customer after passing the final inspection.
 
Event Description
It was reported that the cast vacuum motor is sparking during a cast removal procedure at user facility.The procedure was completed successfully.No delay, no medical intervention and no adverse consequences were reported with this event.
 
Manufacturer Narrative
The device has not been received at the manufacturer for testing. an evaluation will be conducted upon receipt of the device, and a follow-up report will be submitted after the quality investigation is complete.
 
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Brand Name
CASTVAC W/8 FOOT HOSE AND MOBILE STAND
Type of Device
SAW, POWERED, AND ACCESSORIES
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 Key4412027
MDR Text Key5577439
Report Number0001811755-2015-00114
Device Sequence Number1
Product Code HAB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 12/16/2014
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
Device Operator Health Professional
Device Catalogue Number0986000000
Device Lot Number0416100059
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/18/2014
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 03/23/2015
Initial Date FDA Received01/13/2015
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received03/27/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/09/2004
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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