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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO MULTIGEN RADIOFREQUENCY GENERATOR; GENERATOR, LESION, RADIOFREQUENCY
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STRYKER INSTRUMENTS-KALAMAZOO MULTIGEN RADIOFREQUENCY GENERATOR; GENERATOR, LESION, RADIOFREQUENCY Back to Search Results
Catalog Number 0406900000
Device Problem Break (1069)
Patient Problem Therapeutic Effects, Unexpected (2099)
Event Date 10/28/2014
Event Type  malfunction  
Event Description
It was reported that the multigen radiofrequency generator was being used in a procedure when it displayed an error message resulting in the procedure being cancelled and rescheduled for a later date.There were no patient or user injuries, and no adverse consequences.
 
Manufacturer Narrative
Upon evaluation of the device, the board component was found to be broken.The device was repaired and returned to the user facility.
 
Event Description
It was reported that the multigen radiofrequency generator was being used in a procedure when it displayed an error message resulting in the procedure being cancelled and rescheduled for a later date.There were no patient or user injuries, and no adverse consequences.
 
Manufacturer Narrative
A follow up report will be filed after the quality investigation has been completed.
 
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Brand Name
MULTIGEN RADIOFREQUENCY GENERATOR
Type of Device
GENERATOR, LESION, RADIOFREQUENCY
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 Key4275228
MDR Text Key5793670
Report Number0001811755-2014-04264
Device Sequence Number1
Product Code GXD
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K071482
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 10/28/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/25/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number0406900000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/05/2014
Is the Reporter a Health Professional? No
Date Manufacturer Received04/30/2015
Was Device Evaluated by Manufacturer? Yes
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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