MULTIGEN RADIOFREQUENCY GENERATOR

MDR report key: 3002679 · Received March 13, 2013

Report

Report Number: 0001811755-2013-00522
Event Type: Malfunction
Date Received: March 13, 2013
Date of Event: February 28, 2013
Report Date: February 28, 2013
Manufacturer: STRYKER INSTRUMENTS-KALAMAZOO
Product Code: GXD
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THIS SUPPLEMENTAL IS BEING FILED TO ADD THE UNKNOWN ELECTRODES REPORTED ON (B)(4) 2013 AS A CONCOMITANT PRODUCT.

Additional Manufacturer Narrative · 1

THE DEVICE HAS NOT BEEN RECEIVED AT THE MANUFACTURER FOR TESTING. AN EVALUATION WILL BE CONDUCTED UPON RECEIPT OF THE DEVICE, AND A FOLLOW-UP REPORT WILL BE SUBMITTED AFTER THE QUALITY INVESTIGATION IS COMPLETE. THE DEVICE HAS NOT BEEN RETURNED.

Additional Manufacturer Narrative · 1

UPON DISASSEMBLY FOR VISUAL INSPECTION THE ISSUE COULD NOT BE DUPLICATED.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE DEVICE WAS UNABLE TO DETECT ANYTHING DURING A CASE. THE PROCEDURE WAS CANCELLED. THERE WERE NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION REPORTED.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE DEVICE WAS UNABLE TO DETECT ANYTHING DURING A CASE. THE PROCEDURE WAS CANCELED. THERE WERE NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION REPORTED.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE DEVICE WAS UNABLE TO DETECT ANYTHING DURING A CASE. THE PROCEDURE WAS CANCELLED. THERE WERE NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
105460	MULTIGEN RADIOFREQUENCY GENERATOR	GENERATOR, LESION, RADIOFREQUENCY	GXD	STRYKER INSTRUMENTS-KALAMAZOO

Patients

Seq	Age	Sex	Outcome	Treatment
1				UNKNOWN ELECTRODE