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 06/03/2014

Event Type  malfunction  

Event Description

It was reported that during a procedure, the rf generator touch screen was inoperable, which resulted in a cancellation of the procedure.It was reported that the patient was sedated prior to the procedure being canceled.The procedure was rescheduled for the following day and completed successfully.No medical intervention and no adverse consequences were reported with this event.

Event Description

It was reported that during a procedure the rf generator touch screen was inoperable, which resulted in a cancellation of the procedure.It was reported that the patient was sedated prior to the procedure being canceled.The procedure was rescheduled for the following day and completed successfully.No medical intervention and no adverse consequences were reported with this event.

Manufacturer Narrative

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

Manufacturer Narrative

Upon visual inspection, the device was found to have a damaged touch screen.The device was repaired and returned to the user facility.

• 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: 3900246
• MDR Text Key: 20018767
• Report Number: 0001811755-2014-02302
• 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: 06/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2014
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/08/2014
• 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 Number: 1