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 Partial thickness (Second Degree) Burn (2694)

Event Date 06/21/2016

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: carto 3 system, model #m-4800-01, s/n: (b)(4).Coolflow pump, model #m-5491-02, s/n: (b)(4).Ez steer thermocool sf nav, model #d-1313-04-s.Webster cs catheter, model #d-1353-04-s.(b)(4).

Event Description

It was reported that a patient underwent an ablation procedure for atrial fibrillation with a stockert 70 system radiofrequency generator and suffered burns second degree requiring no medical or surgical intervention.After the procedure, blisters were observed on the patient's skin where the grounding pad had been placed.Patient was reported to be in stable condition.Physician did not provide a causality opinion.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.

Manufacturer Narrative

The following was omitted from the initial report in error: this stockert was manufactured before september 24, 2014, therefore no udi is applicable for this product with serial number (b)(4).Manufacturer's reference number: (b)(4).

Manufacturer Narrative

(b)(4).It was reported that a patient underwent an ablation procedure for atrial fibrillation with a stockert 70 system radiofrequency generator and suffered second degree burns requiring no medical or surgical intervention repair follow-up was performed, but service was declined and the device was not shipped.The complaint is not able to be confirmed.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: 5795363
• MDR Text Key: 49574561
• Report Number: 9612355-2016-00042
• 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,Followup
• Report Date: 06/21/2016

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: 06/21/2016
• Initial Date FDA Received: 07/14/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 08/02/2016; 09/27/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2005
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other