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

Model Number M-5463-01

Device Problem Overheating of Device (1437)

Patient Problem Burn(s) (1757)

Event Date 03/27/2014

Event Type  Injury  

Event Description

It was reported that after an atrial flutter (afl) procedure was completed, the physician discovered a skin burn on the patient¿s flank when they removed the indifferent electrode (grounding pad) from the patient.The physician confirmed that the grounding pad was "bunched up¿ on one corner when they went to remove the grounding pad.The burn size is stated to be about 2" x 2." the patient has been referred to a plastic surgeon for probably skin graft.The ep physician has stated that he feels that stockert should have a warning that there is an incomplete adherence to the patient of the grounding pad.Additional information was requested, but no response has been received.

Manufacturer Narrative

The concomitant products: celsius flutter, model # d-1359-01-s, lot # 15921709m.Bard decapolar and a boston scientific duodecapolar.(b)(4).

Manufacturer Narrative

On may 12th 2014, biosense webster received medwatch report # mw5035652 regarding this event.In the medwatch report, it was stated that electro-cautery (covidien, valleylab non- rem polyhesive patient return electrode ref (b)(4)) caused full thickness burn in lumbar region of back and will require skin graft.There was a tiny fold in the pad perimeter w/separation of layers.The cardiac ablation machine used was a biosense webster (model- stockert 70) electrosurgical device, serial no.(b)(4).Alarm was reported to go off twice at 250 ohm with two representatives in the room and the machine reset itself and the procedure was continued.The warning light and alarm did not continue to wound.Facilities checked the room outlets and the bed for any possible shorts and there were none.The other machine had 2 shorts and there were none.The other machine had 2 pads.This machine has 1 connect port for the pad.Manufacturer ref # (b)(4) it was reported that after the procedure was completed that the staff discovered a burn on the patient¿s flank when they removed the indifferent electrode (grounding pad) from the patient.Follow-up was performed and no responses from customer.Service was declined.The device history record was reviewed and no anomalies were found related to this complaint.In addition, the 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-79 111; GM D-79111
• Manufacturer Contact: jaime chavez ; 15715 arrow hwy; irwindale, CA 91706 ; 9098398483
• MDR Report Key: 3751601
• MDR Text Key: 4547728
• Report Number: 9612355-2014-00020
• 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: 03/27/2014

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: 03/27/2014
• Initial Date FDA Received: 04/15/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/29/2014
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention