MAUDE Adverse Event Report: STOCKERT GMBH STOCKERT EP-SHUTTLE RADIO FREQUENCY GENERATOR; RADIOFREQUENCY GENERATOR AND ACCESSORIES/ACCESSORY CABLE

Model Number 39D-76X

Device Problem Insufficient Information (3190)

Patient Problem Full thickness (Third Degree) Burn (2696)

Event Date 03/27/2014

Event Type  Injury  

Event Description

On (b)(6), a notification was received from covidien stating that there were several procedures where a skin burn was a result of it, while using stockert generator (bwi) and covidien products.On (b)(6), a comparison was performed between covidien files reported and our database system and the following event was not found in our system: it was reported that a patient underwent an atrial flutter ablation procedure with a stockert ep-shuttle radio frequency generator and patient suffered a skin burn of third degree.Per 21 cfr, part 803, this complaint is reportable.Further information was requested from covidien and no information was made available.No hardware investigation will be able to perform due to the lack of account and equipment information.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.

Manufacturer Narrative

Due to the limited information, no hardware investigation will be able to perform due to the lack of account and equipment information.(b)(4).

• Brand Name: STOCKERT EP-SHUTTLE RADIO FREQUENCY 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: jaime chavez ; 15715 arrow hwy; irwindale, CA 91706 ; 9098398483
• MDR Report Key: 3877536
• MDR Text Key: 4593071
• Report Number: 9612355-2014-00028
• 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
• Report Date: 05/23/2014

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: 39D-76X
• Device Catalogue Number: 39D-76X
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/23/2014
• Initial Date FDA Received: 06/17/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening