• 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 SURGICAL INSTRUMENT MOTORS AND ACCESSORIES/ATTACHMENTS.

  • 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 SURGICAL INSTRUMENT MOTORS AND ACCESSORIES/ATTACHMENTS. Back to Search Results
Catalog Number 0940000000
Device Problem Device Remains Activated (1525)
Patient Problem No Patient Involvement (2645)
Event Date 03/30/2016
Event Type  malfunction  
Event Description
It was reported that during testing at the user facility that the device would not turn off and would remain activated. No patient involvement, no clinically significant delay, no medical intervention and no adverse consequences were reported with this event.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameCAST CUTTER
Type of DeviceSURGICAL INSTRUMENT MOTORS AND ACCESSORIES/ATTACHMENTS.
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 Key5611400
MDR Text Key43765703
Report Number0001811755-2016-00414
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
Type of Report Initial
Report Date 03/30/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/27/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number0940000000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/20/2016
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/30/2016
Was Device Evaluated by Manufacturer? No
Date Device Manufactured10/09/2007
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-