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

Model Number M-5463-01

Device Problems Device Operates Differently Than Expected (2913); Temperature Problem (3022)

Patient Problem No Code Available (3191)

Event Date 11/24/2015

Event Type  malfunction  

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.(b)(4).

Event Description

It was reported there were intermittent temperature readings from stockert generator during an afib ablation procedure.The issue was not resolved by replacing the catheter cable.The physician cancelled procedure because he couldn't move forward without the generator.This is mdr reportable as it posed risk to patients while the patient was under general anesthesia for one hour and transseptal puncture was already performed prior to case cancellation.

Manufacturer Narrative

Due to the august 2015 fda maintenance where the 3500a codes were updated, the 3500a codes will be added until the biosense webster system is also updated.Therefore the following codes apply: (b)(4).It was reported there were intermittent temperature readings from stockert generator during an afib ablation procedure.The issue was not resolved by replacing the catheter cable.The physician cancelled procedure because he couldn't move forward without the generator.The device was evaluated and no error found.Device is within specification.The device was subjected to pm, 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 Narrative

This stockert was manufactured before september 24, 2014, therefore no udi is applicable for this product.

• 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 ; 9497893837
• MDR Report Key: 5304990
• MDR Text Key: 34529330
• Report Number: 9612355-2015-00068
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2015
• 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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/24/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/31/2001
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1