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

Model Number M-5463-01

Device Problem Insufficient Information (3190)

Patient Problem Burn(s) (1757)

Event Date 06/28/2016

Event Type  Injury  

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: grounding pad.This stockert was manufactured before september 24, 2014, therefore no udi is applicable for this product with serial number (b)(4).Manufacturer's ref.No: (b)(4).

Event Description

It was reported that a patient underwent an ablation procedure for atrial fibrillation with a stockert generator and suffered a skin burn (classification not yet confirmed).It has not been confirmed if the patient required medical or surgical intervention.During the procedure, the patient sustained a burn on the area of the body where the grounding pad was located.There is no information regarding extended hospitalization or patient outcome.Physician did not provide a causality opinion.Generator settings included: power at 20-35 watts and impedance 120-130 ohms.Ablation procedure was 30 minutes in duration with 60 seconds for each lesion.Patient contact area and the indifferent electrode were properly prepared, per the indifferent electrode instructions for use.Indifferent electrode was placed on the patient's back and positioned at a location as close to the heart as possible.It was believed that there were no air pockets present between the skin and the indifferent electrode and that upon opening the package for the grounding pad, the conductive gel was present and moist.There were no error codes reported on any bwi equipment during the procedure.

Manufacturer Narrative

(b)(4).It was reported that a patient underwent an ablation procedure for atrial fibrillation with a stockert generator and suffered a skin burn.The device was evaluated and found to be within specification.No errors were found.The device was subjected to preventative maintenance, safety and functional testing, and all tests passed.No malfunctions were found with the device.A device history record (dhr) review verified 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 ; 33 technology drive; irvine, CA 92618 ; 9497893837
• MDR Report Key: 5818288
• MDR Text Key: 50298210
• Report Number: 9612355-2016-00043
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• 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: 06/30/2016

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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/30/2016
• Initial Date FDA Received: 07/24/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/27/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2004
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other