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

Model Number M-5463-01

Device Problems Device Alarm System (1012); Overheating of Device (1437)

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

Event Date 12/07/2015

Event Type  malfunction  

Manufacturer Narrative

The hardware investigation has begun but it has not been completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.This stockert was manufactured before (b)(6) 2014, therefore no udi is applicable for this.(b)(4).

Event Description

It was reported that a patient underwent a procedure with a stockert 70 rf generator and a high temperature with no error message occurred.The stockert generator was set at 60 degrees celsius and the response from the catheter was at 65 degrees celsius.Upon request additional information was received on the event.A 4mm catheter was used and the temperature cut off was set at 60 degrees celsius with a power of 50 watts.The stockert did not stop ablating when the temperature went above the set cut off of 60 degrees celsius.The system continued to ablate above the temperature cutoff value and within 10 seconds the problem was noticed and ablation was turned off by using the stop button.This event is indicative of a mdr reportable event since the system did not stop ablation when the temperature cut off value was reached.This type of issue could potentially cause patient harm.

Manufacturer Narrative

Due to the august 2015 fda maintenance where the 3500a codes were updated, the 3500a codes will be added until the biosense webster system is also updated.Therefore the following codes apply: (b)(4).It was reported that a patient underwent a procedure with a stockert 70 rf generator and a high temperature with no error message occurred.The device was evaluated and no error was found.The device is within specifications.The device was subjected to preventative maintenance, safety and functional testing and all tests passed.No malfunction was found on the device.The device history record review verifies that the device was manufactured in accordance with documented specification and procedures.

• 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-791 11; GM D-79111
• Manufacturer Contact: joaquin kurz ; 9497893837
• MDR Report Key: 5345447
• MDR Text Key: 35537510
• Report Number: 9612355-2016-00001
• 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,Followup
• Report Date: 12/14/2015

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
• Other Device ID Number: SEE H10.
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/07/2015
• Initial Date FDA Received: 01/05/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1