MAUDE Adverse Event Report: STOCKERT GMBH STOCKERT EP-SHUTTLE RADIO FREQUENCY GENERATOR; SIMILAR DEVICE S7001, PMA # P990071

Model Number 39D-76X

Device Problems Device Operational Issue (2914); No Flow (2991); Noise, Audible (3273)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 04/10/2017

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.Concomitant product: coolflow pump model #: m-5491-01 serial #: (b)(4).Manufacturer's ref.No: (b)(4).

Event Description

It was reported that a patient underwent a procedure with an ep-shuttle rf generator system ¿ 100w.The coolflow pump would switch to 0 ml, stop flowing and beeping during ablation.The response received states the ep-shuttle rf generator system ¿ 100w allowed ablation in automatic mode even when the pump would stop flowing.The procedure was completed by exchanging the cool flow pump to a st.Jude medical pump.There was no patient consequence reported.This event has been assessed as a reportable malfunction under the ep-shuttle rf generator system ¿ 100w as the generator allowed the ablation when the pump would stop flowing.There was the potential for patient injury.

Manufacturer Narrative

Initially, we reported the serial number as unknown.However, additional information was received on (b)(6) 2017 providing the serial number of (b)(4).(b)(4).

Manufacturer Narrative

Follow up was performed and system is now working as specification.No malfunction found on system.The device history record (dhr) review verifies that the device was manufactured in accordance with documented specification and procedures.Manufacturer's reference #: (b)(4).Legacy manufacturer's reference #: (b)(4).

Event Description

It was reported that a patient underwent a procedure with an ep-shuttle rf generator system ¿ 100w.The coolflow pump would switch to 0 ml, stop flowing and beeping during ablation.The response received states the ep-shuttle rf generator system ¿ 100w allowed ablation in automatic mode even when the pump would stop flowing.The procedure was completed by exchanging the cool flow pump to a st.Jude medical pump.There was no patient consequence reported.This event has been assessed as a reportable malfunction under the ep-shuttle rf generator system ¿ 100w as the generator allowed the ablation when the pump would stop flowing.There was the potential for patient injury.

• Brand Name: STOCKERT EP-SHUTTLE RADIO FREQUENCY GENERATOR
• Type of Device: SIMILAR DEVICE S7001, PMA # P990071
• 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: 6546685
• MDR Text Key: 74656532
• Report Number: 9612355-2017-00032
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/10/2017

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: 39D-76X
• Device Catalogue Number: 39D-76X
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/10/2017
• Initial Date FDA Received: 05/05/2017
• Supplement Dates Manufacturer Received: Not provided; 03/10/2017
• Supplement Dates FDA Received: 05/15/2017; 03/08/2018
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1