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 MULTIGEN RADIOFREQUENCY GENERATOR; GENERATOR, LESION, RADIOFREQUENCY
  • 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 MULTIGEN RADIOFREQUENCY GENERATOR; GENERATOR, LESION, RADIOFREQUENCY Back to Search Results
Catalog Number 0406900000
Device Problem Device Inoperable (1663)
Patient Problem Therapeutic Effects, Unexpected (2099)
Event Date 03/03/2015
Event Type  malfunction  
Event Description
It was reported that the multigen radiofrequency generator was being used in a procedure when the device would not power on, resulting in the procedure being rescheduled after the patient was under local anesthesia.There were no patient or user injuries and no adverse consequences.
 
Manufacturer Narrative
A follow up report will be filed after the device is received and the quality investigation is completed.
 
Manufacturer Narrative
The contract manufacturer was not able to confirm the reported event.No error codes or issues with impedance were found by the contract manufacturer.Based on the ifu, it is possible that there was an issue with the electrode or the electrode placement.The replacement of the power entry gasket was a preventive measure and not related to the reported event.
 
Event Description
It was reported that the multigen radiofrequency generator was being used in a procedure when the device would not power on, resulting in the procedure being rescheduled after the patient was under local anesthesia.There were no patient or user injuries and no adverse consequences.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key4662474
MDR Text Key5731871
Report Number0001811755-2015-01252
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,user facility
Reporter Occupation Other
Type of Report Initial
Report Date 03/11/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/06/2015
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? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received08/11/2015
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
-
-