MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO MULTIGEN RADIOFREQUENCY GENERATOR; GENERATOR, LESION, RADIOFREQUENCY

Catalog Number 0406900000

Device Problem Device Inoperable (1663)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Date 04/01/2014

Event Type  malfunction  

Event Description

It was reported that during a procedure at the user facility the touch screen of the multigen radiofrequency generator was not functioning.It was reported that "it looks like someone wiped down the screen and used too much cleaning agent, seeped in underneath the screen and there is a bubble under the screen".As a result, the procedure had to be canceled.It was reported that the patient had received "mac anesthesia" prior to the procedure being canceled.It was reported that the procedure was rescheduled and completed successfully.No medical intervention was reported with this event.

Event Description

It was reported that during a procedure at the user facility, the touch screen of the multigen radiofrequency generator was not functioning.It was reported that "it looks like someone wiped down the screen and used too much cleaning agent, seeped in underneath the screen and there is a bubble under the screen." as a result, the procedure had to be canceled.It was reported that the patient had received "mac anesthesia" prior to the procedure being canceled.It was reported that the procedure was rescheduled and completed successfully.No medical intervention was 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 touch screen was found to be damaged.The device was repaired and returned to the user facility.

• 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 Key: 3767327
• MDR Text Key: 4553312
• Report Number: 0001811755-2014-01464
• 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: 04/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0406900000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/16/2014
• 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