MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO RF GEN OBSOLETE REPLACED BY 0406900000; GENERATOR, LESION, RADIOFREQUENCY

Catalog Number 0406800000

Device Problem Device Inoperable (1663)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/12/2014

Event Type  malfunction  

Event Description

It was reported that during a procedure the rf generator screen turned black during sensory stimulation.As a result, the procedure was canceled.It was reported that the patient received anesthesia prior to the procedure being canceled.

Event Description

It was reported that during a procedure the rf generator screen turned black during sensory stimulation.As a result, the procedure was canceled.It was reported that the patient received anesthesia prior to the procedure being canceled.

Manufacturer Narrative

A follow up report will be filed after the quality investigation has been completed.

Manufacturer Narrative

The device was not available for evaluation, therefore, the reported event could not be confirmed.

• Brand Name: RF GEN OBSOLETE REPLACED BY 0406900000
• 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 Key: 4039889
• MDR Text Key: 4902120
• Report Number: 0001811755-2014-03046
• Device Sequence Number: 1
• Product Code: GXD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071482
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0406800000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/13/2014
• 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 Number: 1