Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO CAST CUTTER, 18 INCH CORD "; SAW, POWERED, AND ACCESSORIES
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

STRYKER INSTRUMENTS-KALAMAZOO CAST CUTTER, 18 INCH CORD "; SAW, POWERED, AND ACCESSORIES Back to Search Results
Catalog Number 0848000000
Device Problem Smoking (1585)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/17/2015
Event Type  malfunction  
Event Description
It was that power switch in the cast cutter was smoking during a cast removal procedure at the user facility.The procedure was completed successfully.No delay, no medical intervention and no adverse consequences were reported with this event.
 
Manufacturer Narrative
Failure analysis is in progress; additional information will be submitted once the quality investigation is completed.
 
Manufacturer Narrative
The reported event, unit started smoking, was not duplicated.However, it was confirmed as a non-stryker switch and cord assembly were found installed in the device, which can cause or contribute to the device smoking.Through inspection, the service technician also noted that the device failed to run.
 
Event Description
It was that power switch in the cast cutter was smoking during a cast removal procedure at the user facility.The procedure was completed successfully.No delay, no medical intervention and no adverse consequences were reported with this event.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
CAST CUTTER, 18 INCH CORD "
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 Key4913284
MDR Text Key6437247
Report Number0001811755-2015-02557
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,user facility
Reporter Occupation Other
Type of Report Initial
Report Date 06/17/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/14/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number0848000000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/19/2015
Is the Reporter a Health Professional? No
Date Manufacturer Received09/02/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/19/2009
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
-
-