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

Model Number M-5463-01

Device Problems No Device Output (1435); Loss of Power (1475); Device Displays Incorrect Message (2591)

Patient Problem Injury (2348)

Event Date 07/29/2014

Event Type  malfunction  

Event Description

It was reported that a female patient (b)(6), underwent an atrial fibrillation procedure with a stockert 70 rf generator, and a radio frequency delivery problem and hardware error malfunction occurred and turned off the ablation.The procedure got cancelled without patient consequence.This event was originally considered non-reportable, however, bwi became aware that patient was under general anesthesia and had a transseptal puncture during the event and have reassessed the event as reportable.

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.(b)(4).

Manufacturer Narrative

B(b)(4).It was reported that a female patient 67 years old, underwent an atrial fibrillation procedure with a stockert 70 rf generator, and a radio frequency delivery problem and hardware error malfunction occurred and turned off the ablation.The investigational analysis has been completed.Follow-up was performed and po was not provided.Service was declined.The device history record was reviewed and no anomalies were found related to this complaint.In addition, the dhr 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-79 111; GM D-79111
• Manufacturer Contact: jaime chavez ; 15715 arrow hwy; irwindale, CA 91706 ; 9098398483
• MDR Report Key: 4018540
• MDR Text Key: 18366254
• Report Number: 9612355-2014-00039
• 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: 07/29/2014

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/29/2014
• Initial Date FDA Received: 08/18/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/25/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 67 YR