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

Model Number M-5463-01

Device Problem Communication or Transmission Problem (2896)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/04/2014

Event Type  malfunction  

Event Description

It was reported that during an atrial fibrillation (afib) procedure using a stockert generator, a communication issue occurred between the generator and the carto system, the visualization system.The carto system indicated that the concomitant ablation catheter was not delivering radio frequency (rf) energy, while the stockert generator showed that rf energy was being delivered.There were no errors displayed.The case was completed successfully, with no patient consequence by exchanging the generator with a similar like device.This event is reportable due to patient risk associated with such an issue.

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Concomitant products: carto 3 system, serial # unk.(b)(4).The hardware investigation has begun, but is not complete at this time.

Manufacturer Narrative

Evaluation summary.(b)(4).It was reported that during an atrial fibrillation (afib) procedure using a stockert generator, a communication issue occurred between the generator and the carto system, the visualization system.The carto system indicated that the concomitant ablation catheter was not delivering radio frequency (rf) energy, while the stockert generator showed that rf energy was being delivered.There were no error messages displayed.The device was evaluated by bwi and no issues were found.The device performed within specification.The device was subjected to pm, safety, and functional testing and all tests passed.No malfunction found on device.The device history record for stockert generator serial number (b)(4) shows that no manufacturing or test fails were noted during the manufacturing cycle related to functionality of the device.The device met all requirements prior to distribution.

• 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: jaime chavez ; 9098398483
• MDR Report Key: 4367941
• MDR Text Key: 16539824
• Report Number: 9612355-2014-00062
• 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: 12/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M-5463-01
• Device Catalogue Number: S7001
• Other Device ID Number: (1)4260166370195
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/04/2014
• Initial Date FDA Received: 12/30/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/05/2015
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1