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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; INSTRUMENT, CAST REMOVAL, AC-POWERED
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STRYKER INSTRUMENTS-KALAMAZOO CASTVAC W/8 FOOT HOSE AND MOBILE STAND; INSTRUMENT, CAST REMOVAL, AC-POWERED Back to Search Results
Catalog Number 0986000000
Device Problems Electrical /Electronic Property Problem (1198); Cut In Material (2454)
Patient Problem No Patient Involvement (2645)
Event Date 05/06/2015
Event Type  malfunction  
Event Description
It was reported that during inspection at the user facility, the cord was cut.This could result in exposed wires and a risk of electrical shock.No patient involvement, no delay, no medical intervention and no adverse consequences were reported with this event.
 
Manufacturer Narrative
The reported event was confirmed.Service evaluation observed that the cord was cut.The device was repaired and returned to the customer.
 
Event Description
It was reported that during inspection at the user facility, the cord was cut.This could result in exposed wires and a risk of electrical shock.No patient involvement, no delay, no medical intervention and no adverse consequences were reported with this event.
 
Manufacturer Narrative
The device was received for evaluation; additional information will be submitted once the quality investigation is completed.Failure analysis is in progress.
 
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Brand Name
CASTVAC W/8 FOOT HOSE AND MOBILE STAND
Type of Device
INSTRUMENT, CAST REMOVAL, AC-POWERED
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 Key4815575
MDR Text Key6192333
Report Number0001811755-2015-02011
Device Sequence Number1
Product Code LGH
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 05/11/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/03/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number0986000000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/19/2015
Is the Reporter a Health Professional? No
Date Manufacturer Received07/20/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/18/2005
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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