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

Model Number M-5463-01

Device Problems Use of Device Problem (1670); Malposition of Device (2616)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 06/06/2017

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.This stockert 70 system 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 atrial flutter (afl) procedure with a stockert 70 system and suffered a second degree burn which required silvidine cream and a dressing.During the procedure, second degree burns were noticed on the patient¿s left lower back.The patient required silvidine cream and a dressing.The patient was reported to be in stable condition.There is no information about the hospitalization.It was discovered that the covidien grounding pads were placed incorrectly.The patient was larger.When the patient laid back, the patch folded as it was almost completely lifted from the skin.The indifferent electrode wasn¿t positioned at a location on the back as close to the heart as possible as it could have been closer.However, it was not too far away.While opening the packaging, there was conductive gel present on the indifferent electrode and the indifferent electrode was moist.The indifferent electrode was at least 124 cm2.Impedance was around 160, power 40w.There were no error codes reported on the generator in this procedure.It was noticed that they did not experience signal reduction.Troubleshooting was performed.However, no further information provided on this no signal reduction.It was also reported that no impedance displayed.The cables and catheter were replaced and the system was rebooted without resolution.The grounding pads were replaced and the issue resolved.This impedance issue was assessed as not reportable.The potential risk that it could cause or contribute to a death or serious deterioration in state of health was remote.Since the 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

Manufacturer's ref.No: (b)(4) it was reported that a female patient underwent an atrial flutter (afl) procedure with a stockert 70 system.During the procedure, second degree burns were noticed on the patient¿s left lower back.The patient required silvidine cream and a dressing.The patient was reported to be in stable condition.There is no information about the hospitalization.It was discovered that the covidien grounding pads were placed incorrectly.The patient was larger.When the patient laid back, the patch folded as it was almost completely lifted from the skin.The indifferent electrode wasn¿t positioned at a location on the back as close to the heart as possible as it could have been closer.However, it was not too far away.While opening the packaging, there was conductive gel present on the indifferent electrode and the indifferent electrode was moist.The indifferent electrode was at least 124 cm2.Impedance was around 160, power 40w.There were no error codes reported on the generator in this procedure.It was noticed that they did not experience signal reduction.Troubleshooting was performed.However, no further information provided on this no signal reduction.It was also reported that no impedance displayed.The cables and catheter were replaced and the system was rebooted without resolution.The grounding pads were replaced and the issue resolved.Repair follow-up was performed and device was not shipped for service.Service was declined.Complaint was unable to be confirmed.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 ; 33 technology drive; irvine, CA 92618 ; 9497893837
• MDR Report Key: 6673726
• MDR Text Key: 78599601
• Report Number: 9612355-2017-00036
• 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: 06/06/2017

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: 06/06/2017
• Initial Date FDA Received: 06/28/2017
• Supplement Dates Manufacturer Received: 06/06/2017
• Supplement Dates FDA Received: 08/23/2017
• 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