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

Model Number M-5463-01

Device Problem Improper or Incorrect Procedure or Method (2017)

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

Event Date 05/03/2016

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 products: smart touch bidirectional catheter, model # d-1327-05-s, lot number unknown.3m grounding pad, model # 9135-lp, lot number unknown.This stockert 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 patient underwent an ablation procedure with a stockert generator and suffered burns second degree requiring surgical intervention (debridement).During a follow-up appointment, the physician noticed that the patient had a grounding pad burn.Intervention was debridement.Patient did not required extended hospitalization as a result of this adverse event.Patient outcome after debridement was improved.Physician's opinion regarding the cause of the adverse event is that it was related to the type of grounding pad used.The 3m grounding pad (9135-lp) was noted to be 97 cm square.There is no information regarding generator settings.Patient contact area and the indifferent electrode were properly prepared per the indifferent electrode instructions for use.Indifferent electrode was placed on the patient's back.It was noted that the patch was prepared and placed in the usual fashion.Indifferent electrode used with the stockert generator was 97 cm square (not 124 cm square or larger).There were no error codes reported on the stockert generator, and service on the generator was declined.

Manufacturer Narrative

(b)(4).It was reported that a patient underwent an ablation procedure with a stockert generator and suffered burns second degree requiring surgical intervention (debridement).Repair follow-up was performed, but the service was declined and the device was not shipped.The complaint is not able to be confirmed.A device history record (dhr) review verified 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: 5818306
• MDR Text Key: 50297167
• Report Number: 9612355-2016-00044
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• 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: 07/01/2016

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: 06/30/2016
• Initial Date FDA Received: 07/24/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/27/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2010
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention