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 11/10/2015

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.We are working on udi information, once we get more information it will be submitted in the supplemental.Concomitant product: carto 3 system: model #: m-4800-01, serial #:(b)(4); coolflow pump: model #:m-5491-02, serial #:(b)(4).(b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation /atrial flutter procedure using a stockert 70 system and suffered a third degree skin burn requiring grafting.During the procedure (phase unknown), it was discovered that only one corner of the grounding pad was in contact with the patient's skin.A new pad was applied and the procedure resumed and was completed successfully.After the procedure, it was discovered that the patient had a burn underneath the grounding pad.The patient did require extended hospitalization for the purpose of skin grafting and recovery.The patient was reported to be in stable condition at the time the complaint was reported.The patient contact area and the indifferent electrode were properly prepared per the indifferent electrode instructions for use.The physician's opinion regarding the cause of this adverse event is that it was due to the grounding pad not being in full contact with the patient's skin.There were no error messages reported.Generator setting included: 30 watts; impedance 212-240 during mapping, 240 on first ablation, and 140 for the remainder of ablations.Since this adverse event required medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure, it is to be considered serious and mdr reportable.

Manufacturer Narrative

On january 4, 2016 additional information was provided on the manufacturer date.Therefore, the udi number is (b)(4).Manufacturer's ref.No: (b)(4).

• 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 ; 9497893837
• MDR Report Key: 5287198
• MDR Text Key: 33246262
• Report Number: 9612355-2015-00061
• 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: 11/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 11/11/2015
• Initial Date FDA Received: 12/10/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/28/2016
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention