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); Infusion or Flow Problem (2964); Positioning Problem (3009)

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

Event Date 04/25/2016

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.This stockert was manufactured before september 24, 2014, therefore no udi is applicable for this product with serial number (b)(4) are related to the same incident.(b)(4).

Event Description

It was reported that a patient underwent an atrioventricular nodal reentrant tachycardia (avnrt) procedure with a coolflow pump and a stockert 70 system and it would not go to low flow.It stays at a flow rate of 30 ml/min and will not go to a flow rate of 2 ml/min.The procedure was completed with no patient consequences.A day after the procedure, troubleshooting was performed for this issue.A web bath was set up and the interface cable was reseated in the back of the pump.Multiple settings were selected and radiofrequency energy was started.The pump performed as designed and there were no errors.Flow rates were appropriate.They stated that the pump was ready for use as it was determined that the interface cable was not seated correctly.Since the coolflow pump did not switch to the low flow rate, this issue was assessed as a reportable malfunction under the coolflow pump as this issue could potentially lead to patient volume overload.On june 28, 2016 additional information was received stating that the stockert 70 system was set to auto mode, power control at 30 watts and there were no error messages.Since the generator was set to auto mode and there was no error message, the generator has now also been assessed as a reportable malfunction.The awareness date for this product issue is june 28, 2016.

Manufacturer Narrative

Manufacturer's ref.No: (b)(4).It was reported that a patient underwent an atrioventricular nodal reentrant tachycardia (avnrt) procedure with a coolflow pump and a stockert 70 system and it would not go to low flow.It remained at a flow rate of 30 ml/min and would not go to a flow rate of 2 ml/min.The procedure was completed with no patient consequences.A day after the procedure, troubleshooting was performed for this issue.A web bath was set up and the interface cable was reseated in the back of the pump.Multiple settings were selected and radiofrequency energy was started.The pump performed as designed and there were no errors.Flow rates were appropriate.They stated that the pump was ready for use as it was determined that the interface cable was not seated correctly.The device history record (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-791 11; GM D-79111
• Manufacturer Contact: joaquin kurz ; 33 technology drive; irvine, CA 92618 ; 9497893837
• MDR Report Key: 5792836
• MDR Text Key: 50392389
• Report Number: 9612355-2016-00041
• 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: 04/27/2016

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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/27/2016
• Initial Date FDA Received: 07/13/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1