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 11/09/2015

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.(b)(4).Concomitant product: 1.Carto 3 system, model #: unknown, serial # unknown.2.Navigational 8m f curve ablation catheter, model #: unknown, lot #: unknown.3.Non bwi - conmed thermogard indifferent electrode patch.(b)(4).Rf application will not start if the indifferent electrode is missing or connected improperly to the stockert 70 rf generator.¿ the ifu also states in the warnings and precautions during ablation therapy, ¿¿ read and follow the disposable indifferent (dispersive) patch (dip) electrode manufacturer¿s instructions for use; the use of dip electrodes, which meet or exceed ansi/aami hf-18 requirements is recommended.¿.

Event Description

It was reported that a (b)(6) male patient underwent a right atrial flutter procedure with a stockert 70 system and suffered a skin burn which required treatment.It was found post procedure that the patient sustained burns to the right lower back, degree unknown.Treatment included washing the affected area with soapy water, hydrocortisone, and aloe ointment.The patient did not require extended hospitalization as a result.The patient was in stable condition at the time the complaint was reported.The physician's opinion regarding the cause is unknown.The indifferent electrode patch that may be suspect as a contributor was a conmed thermogard.It was described that the patch was placed on the right lower back flank area.It was not positioned at a location of the patient's back as close to the heart as possible.Further, the patch appeared normal in appearance and was placed in the usual fashion.There were no error codes noted on the generator.Generator settings included: impedance averaging 110, power setting at 55 (which was increased to 70 for the last 3 ablations), and temperature setting 55.There were 9 ablations with a total time of 17 minutes and 31 seconds.Since this event required medical intervention to preclude permanent impairment of a body function or permanent damage to a body structure, this event is considered serious and mdr reportable.There appear to have been deviations in the procedure and the recommended bwi instructions for use.In the instructions for use (ifu) it states in the warnings and precautions specific to the stockert 70 rf generator, "to avoid low output or failure of the ablation device at normal operating setting, ensure there is appropriate positioning of the indifferent electrode and proper connection with the connecting cable.

Manufacturer Narrative

Due to the august 2015 fda maintenance were the 3500a codes were updated, the 3500a codes will be added until the biosense webster system is also updated.(b)(4).It was reported that a (b)(6) male patient underwent a right atrial flutter procedure with a stockert 70 system.It was found post procedure that the patient sustained burns to the right lower back, degree unknown.Treatment included washing the affected area with soapy water, hydrocortisone, and aloe ointment.The patient did not require extended hospitalization as a result.The patient was in stable condition at the time the complaint was reported.The indifferent electrode patch that may be suspect as a contributor was a conmed thermogard.It was described that the patch was placed on the right lower back flank area.The patch appeared normal in appearance and was placed in the usual fashion.There were no error codes noted on the generator.Generator settings included: impedance averaging 110, power setting at 55 (which was increased to 70 for the last 3 ablations), and temperature setting 55.There were 9 ablations with a total time of 17 minutes and 31 seconds stockert could not duplicate patient injury complaint.Performed functional and safety test.System is ready for use.The device history record (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-791 11; GM D-79111
• Manufacturer Contact: joaquin kurz ; 9497893837
• MDR Report Key: 5271540
• MDR Text Key: 32867237
• Report Number: 9612355-2015-00060
• 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: 11/09/2015

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: 11/09/2015
• Initial Date FDA Received: 12/07/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/05/2016
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Weight: 84