MAUDE Adverse Event Report: STOCKERT GMBH STOCKERT 70 RF GENERATOR; RADIOFREQUENCY GENERATOR AND ACCESSORIES/ACCESSORY CABLE

Model Number M-5463-01

Device Problems Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/17/2013

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.(b)(4).

Event Description

During an atrial fibrillation procedure, it was reported that after ablating with the thermocool sf nav bi-directional catheter, the temperatures displayed on the stockert 70 rf generator were low.The redel cable from the generator to the patient unit interface (piu) was replaced, as well as the ablation cable and the issue remained.The catheter was replaced and the problem was resolved.The procedure was completed with the same equipment.There were no patient consequences.On (b)(4), received additional information requested from bwi representative confirming that the drop occurred when ablating was being performed.During the setup, the catheter was properly selected.On the carto, stockert as well as in the ep recording system, the temperature was always available and correct.The catheter replaced that resolve the issue was an identical type of device.As per the current and available information, this event became reportable due to a low temperature being displayed while performing ablation.

• Brand Name: STOCKERT 70 RF GENERATOR
• Type of Device: RADIOFREQUENCY GENERATOR AND ACCESSORIES/ACCESSORY CABLE
• Manufacturer (Section D): STOCKERT GMBH; boetzinger strasse 72; freiburg, b-w D-791 11; GM D-79111
• Manufacturer (Section G): STOCKERT GMBH; boetzinger strasse 72; freiburg, b-w D-79 111; GM D-79111
• Manufacturer Contact: diana thorson ; 15715 arrow hwy; irwindale, CA 91706 ; 9098398604
• MDR Report Key: 3582892
• MDR Text Key: 22214767
• Report Number: 9612355-2014-00003
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P990071
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/17/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M-5463-01
• Device Catalogue Number: S7001
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/17/2013
• Initial Date FDA Received: 01/21/2014
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1