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

Model Number 39D-76X

Device Problems Excess Flow or Over-Infusion (1311); Mechanical Jam (2983)

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

Event Date 06/09/2015

Event Type  malfunction  

Event Description

It was reported that during the last ablation of atrial flutter (afl) procedure, the foot pedal jammed and the physician stated it took more than one attempt to stop the delivery of radio frequency energy.The procedure was completed without any patient consequences using the same device.This type of issue is assessed as reportable event.In addition, the customer experienced a carto 3 location patch issue during the case however this issue is not reportable.

Manufacturer Narrative

The concomitant product: carto 3 model# m-4800-01 serial # (b)(4).(b)(4).

Manufacturer Narrative

(b)(4).It was reported that during the last ablation of atrial flutter (afl) procedure, the foot pedal jammed and the physician stated it took more than one attempt to stop the delivery of radio frequency energy.The procedure was completed without any patient consequences using the same device.This type of issue is assessed as reportable event.Device was evaluated and foot pedal was physically fault.Defected part was replaced.Issue was resolved.Repair follow-up was performed but no other information was provided.The dhr review verifies that the device was manufactured in accordance with documented specification and procedures.

• 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: shahe garabedian ; 9098397362
• MDR Report Key: 4895981
• MDR Text Key: 21928849
• Report Number: 9612355-2015-00032
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: EI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/09/2015

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: 06/09/2015
• Initial Date FDA Received: 07/07/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1