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

Model Number M-5463-01

Device Problems Device Alarm System (1012); High impedance (1291); Defective Component (2292)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/02/2014

Event Type  malfunction  

Event Description

It was reported that during an ablation procedure using a stockert generator, the high impedance cut-off function was found defective.During the case, high impedance was observed and the generator did not stop nor did it produce errors, making the event reportable.The procedure was finished successfully with the complaint device.No adverse patient consequences were reported.

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Concomitant products: 8mm ds catheter, lot # unk.(b)(4).The hardware investigation has begun but it has not been completed at this time.

Manufacturer Narrative

Evaluation summary: (b)(4).It was reported that during an ablation procedure using a stockert generator, the high impedance cut-off function was found defective.During investigation, the complaint was duplicated, the stockert generated a hardware error 5.The device was evaluated and the bux48 transistor was found to be defected.The defected part was replaced.Issue was resolved.The device was also subjected to pm, safety and functional testing and all tests passed.The system is ready for use.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: 4375137
• MDR Text Key: 5258884
• Report Number: 9612355-2014-00066
• 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: 12/02/2014

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: 12/02/2014
• Initial Date FDA Received: 12/31/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/11/2015
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1