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

Model Number M-5463-01

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 06/27/2016

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: carto 3 system, model # m-4800-01, s/n: (b)(4).Smart touch bidirectional catheter, model # d-1327-05-s.3m grounding pad, model # 9135-lp.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 (unspecified) with a stockert generator and suffered burns second degree.There is no information regarding intervention provided.During a follow-up visit for a separate medical issue, the physician noticed that the patient had a grounding pad burn.Patent did not require extended hospitalization as a result of this event.It was noted that the account used a 97cm square 3m grounding pad (9135-lp).Physician's opinion regarding the cause of the adverse event is that it was related to the type of grounding pad, the 3m 9135-lp.Patient contact area and indifferent electrode were properly prepared, per the indifferent electrode instructions for use.Indifferent electrode was placed on the patient's back.Indifferent electrode used with the stockert generator was 97 cm square (not 124 cm square or larger).No error codes were reported on the stockert generator, and service for the generator was declined.Attempts have been made to obtain clarification to this complaint.However, no further information has been made available.

Manufacturer Narrative

(b)(4).It was reported that a patient underwent an ablation procedure (unspecified) with a stockert generator and suffered second degree burns.Repair follow-up was performed, but 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: 5818305
• MDR Text Key: 50298982
• Report Number: 9612355-2016-00045
• 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: 06/01/2011
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other