MAUDE Adverse Event Report: STOCKERT GMBH STOCKERT 70 RF GENERATOR; .

Model Number M-5463-01

Device Problem Insufficient Information (3190)

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

Event Date 03/15/2017

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 was manufactured before september 24, 2014.As such, udi does not apply to this product.B)(4).

Event Description

It was reported that a patient underwent an ablation procedure with a stockert 70 system generator and suffered burns second degree.Post-procedure, skin burns were observed on the patient¿s right lower back.Patient was reported to be in stable condition.Multiple attempts have been made to obtain clarification to this complaint.No further information has been made available.This event is being conservatively reported as second degree burns, as the burn classification was never received.

Manufacturer Narrative

On 1/17/2018, the date of manufacture for the stockert generator serial # (b)(6) was received as april 21, 2011.Device manufacture date has been populated.Device evaluation details: it was reported that a patient underwent an ablation procedure with a stockert 70 system generator and suffered burns second degree.Post-procedure, skin burns were observed on the patient¿s right lower back.Patient was reported to be in stable condition.The device evaluation has been completed.The device was evaluated and no error found.The device is within specification.The device was subjected to preventative maintenance, safety and functional testing and all tests passed.No malfunction found on device.The dhr review verifies that the device was manufactured in accordance with documented specification and procedures.Manufacturer¿s ref # (b)(4).

• Brand Name: STOCKERT 70 RF GENERATOR
• Type of Device: .
• Manufacturer (Section D): STOCKERT GMBH; boetzinger strasse 72; freiburg, b-w D-791 11; GM D-79111
• MDR Report Key: 6731073
• MDR Text Key: 80622407
• Report Number: 9612355-2017-00037
• 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
• Type of Report: Initial,Followup
• Report Date: 07/03/2017

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
• Initial Date Manufacturer Received: 07/03/2017
• Initial Date FDA Received: 07/21/2017
• Supplement Dates Manufacturer Received: 01/17/2019
• Supplement Dates FDA Received: 02/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other