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

Model Number M-5463-01

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 03/15/2017

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: conmed thermogard indifferent electrode (51-7810); 8 mm catheter (model# unknown lot# unknown).This stockert was manufactured before september 24, 2014; therefore, no udi is applicable for this product with serial number (b)(4).

Event Description

It was reported that a female patient underwent an ablation procedure for atrial flutter with a stockert 70 rf generator and suffered third degree burns requiring antibiotics, hydrocortisone, and benadryl cream.Post-procedure, while in the recovery room, a skin burn was noticed where the grounding pad had been.An unspecified intervention was performed.Patient was reported to be in stable condition.Patient did not require extended hospitalization as a result of the adverse event.Clinical situation worsened prior to discharge, but improved by the follow-up clinic visit.Physician¿s opinion regarding the cause of the adverse event is that it was related to sub optimal skin contact of the grounding pad secondary to the patient¿s body habitus.Patient contact area and the indifferent electrode were properly prepared per the indifferent electrode instructions for use.Indifferent electrode was placed on the abdomen.The entire surface area of the grounding pad was in complete contact with the patient¿s abdomen.There were no air pockets present between the skin and the indifferent electrode.Upon opening the package for the grounding pad, the conductive gel was present on the indifferent electrode.Upon opening the package for the grounding pad, the indifferent electrode was moist.Generator settings included power at 70 watts and 70°c for approximately five two minute ablations.There were no error codes on the stockert generator during the procedure.

Manufacturer Narrative

(b)(4).It was reported that a female patient underwent an ablation procedure for atrial flutter with a stockert 70 rf generator and suffered third degree burns requiring antibiotics, hydrocortisone, and benadryl cream.Repair follow-up was performed and device was not shipped for service.Service was declined.The device history record review verifies that the device was manufactured in accordance with documented specification and procedure.Complaint was unable to be confirmed.

• 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: 6472045
• MDR Text Key: 72112889
• Report Number: 9612355-2017-00024
• 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: 03/17/2017

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: 03/17/2017
• Initial Date FDA Received: 04/07/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention