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

Model Number M-5463-01

Device Problem Overheating of Device (1437)

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

Event Date 12/31/2013

Event Type  Injury  

Event Description

On (b)(4) 2014, bwi received information from the account regarding this event.Per the information provided by the account, a patient underwent cardiac ablation procedure on (b)(6) 2013.It was alleged that during the patient's follow up visit to the cardiologist, the patient was noted to have sustained a burn where the grounding pad had been placed during the ep procedure.No prior notice of this alleged event was reported prior to (b)(6) 2014.During additional investigation with the bwi representative, it was found that in (b)(4) 2014, the bwi representative was informed about this event which resulted in skin burn.Based on the information received, the degree of the skin burn remains unknown; however, second degree skin burn cannot be ruled out making this event reportable.

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 used: product name: 8 fr rmt nav thermocool, us catalog #: unknown, lot#: unknown.(b)(4).

Manufacturer Narrative

Evaluation summary: (b)(4).On (b)(6) 2014, bwi received information from the account regarding this event.Per the information provided by the account, a patient underwent cardiac ablation procedure on (b)(6) 2013.It was alleged that during the patient's follow up visit to the cardiologist, the patient was noted to have sustained a burn where the grounding pad had been placed during the ep procedure.No prior notice of this alleged event was reported prior to (b)(6) 2014.During additional investigation with the bwi representative, it was found that in (b)(6) 2014, the bwi representative was informed about this event which resulted in skin burn.Based on the information received, the degree of the skin burn remains unknown however second degree skin burn cannot be ruled out making this event reportable.The investigational analysis has been completed.It was confirmed that it was non bwi related issue.Device is working fine.No malfunction of device reported.Customer does not want the system checked.The device history record was reviewed and no anomalies were found related to this complaint.In addition, the 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-79 111; GM D-79111
• Manufacturer Contact: diana thorson ; 15715 arrow hwy; irwindale, CA 91706 ; 9098398604
• MDR Report Key: 4165100
• MDR Text Key: 4867870
• Report Number: 9612355-2014-00045
• 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: 09/16/2014

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/11/2014
• Initial Date FDA Received: 10/10/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/14/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 83 YR