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

Model Number M-5463-01

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Full thickness (Third Degree) Burn (2696)

Event Date 06/16/2014

Event Type  Injury  

Event Description

It was reported that a patient underwent a paroxysmal atrial fibrillation procedure with a stockert 70 rf generator and suffered a third degree skin burn which required a skin graft.The patient¿s medical history is unknown.There is no further information about hospitalization.The procedure was completed successfully.The physician did not provide a causality opinion for the cause of this adverse event.Per 21 cfr, part 803, this complaint is 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.Concomitant products used: product name: carto® 3 system: us catalog #: fg540000, serial #: 1(b)(4).Product name: thermocool® sf nav bi-directional catheter: us catalog #: bni35ffh, lot #: unknown.(b)(4).

Manufacturer Narrative

Evaluation summary.Manufacturer's ref.No: (b)(4).It was reported that a patient underwent a paroxysmal atrial fibrillation procedure with a stockert 70 rf generator and suffered a third degree skin burn which required a skin graft.The patient¿s medical history is unknown.There is no further information about hospitalization.The procedure was completed successfully.It was confirmed that the injury was caused by an incomplete grounding patch contact with the patient.No error found.Device is within specification.No malfunction found on device.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: diana thorson ; 15715 arrow hwy; irwindale, CA 91706 ; 9098398604
• MDR Report Key: 4119842
• MDR Text Key: 4946447
• Report Number: 9612355-2014-00041
• 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: 08/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M-5463-01
• Device Catalogue Number: S7001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/29/2014
• Initial Date FDA Received: 09/25/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/03/2014
• 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
• Patient Outcome(s): Life Threatening; Required Intervention