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

Model Number M-5463-01

Device Problems Device Displays Incorrect Message (2591); Malposition of Device (2616)

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

Event Date 05/19/2016

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 product: thermocool sf catheter, model #: unknown, lot #: unknown.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 ablation procedure for right atrial flutter with a stockert 70 system and suffered a second degree burn under the indifferent electrode requiring topical ointment/dressing and monitoring.During the procedure, impedance ranged from 190-210 ohms.A high impedance error message populated, indicating that the impedance cut-off of 250 ohms was met.The system stopped ablation, as expected.At the end of the procedure, the staff noticed that the valleylab indifferent electrode, on the left posterior thigh, was wrinkled and not in complete contact with the skin.It was determined that patient movement during the procedure may have resulted in the displacement (rolling) of the patch.There is no information regarding extended hospitalization.The patient outcome is improved.The physician's opinion regarding the cause of the adverse event is that it was related to poor placement of the indifferent electrode and patient movement that resulted in incomplete electrode contact.Generator settings included the power control mode at 35-40 watts and impedance of 190-210 ohms.At the beginning of the case, the patient contact area and indifferent electrode were properly prepared per the instructions for use (ifu) and the entire surface area of the grounding pad was in complete contact with the skin.The indifferent electrode was not positioned on the back as close to the heart as possible.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

(b)(4).It was reported that a female patient underwent an ablation procedure for right atrial flutter with a stockert 70 system and suffered a second degree burn under the indifferent electrode requiring topical ointment/dressing and monitoring.During the procedure, impedance ranged from 190-210 ohms.A high impedance error message populated, indicating that the impedance cut-off of 250 ohms was met.The system stopped ablation, as expected.At the end of the procedure, the staff noticed that the valleylab indifferent electrode, on the left posterior thigh, was wrinkled and not in complete contact with the skin.It was determined that patient movement during the procedure may have resulted in the displacement (rolling) of the patch.There is no information regarding extended hospitalization.The patient outcome is improved.Repair follow-up was performed and the device will not shipped for service.Service was declined.The device was unable to be evaluated.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: 5730878
• MDR Text Key: 47594796
• Report Number: 9612355-2016-00036
• 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: 05/19/2016

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: 05/19/2016
• Initial Date FDA Received: 06/16/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention