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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 Electrical /Electronic Property Problem (1198)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/27/2015
Event Type  malfunction  
Event Description
It was reported that the screen on the multigen radiofrequency generator was freezing up during a procedure, as a result the procedure was canceled.There were no adverse consequences or medical intervention reported.
 
Event Description
It was reported that the screen on the multigen radiofrequency generator was freezing up during a procedure, as a result the procedure was canceled.There were no adverse consequences or medical intervention reported.
 
Manufacturer Narrative
The contract manufacturer was able to confirm the reported event.The touch screen was found to have moisture infiltration and was inoperative.As the device functioned properly after the touch screen was replaced, the root cause was determined to be due to the touch screen failure.The device was repaired and returned to the customer.
 
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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 Key4867464
MDR Text Key5812588
Report Number0001811755-2015-02308
Device Sequence Number1
Product Code GXD
Combination Product (y/n)N
Reporter Country CodeUS
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 05/27/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/25/2015
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number0406900000
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received07/16/2015
Was Device Evaluated by Manufacturer? No
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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