MAUDE Adverse Event Report: STOCKERT GMBH; SIMILAR DEVICE S7001, PMA # P990071

Model Number M-5463-320

Device Problem Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/29/2016

Event Type  malfunction  

Manufacturer Narrative

The 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.Contact office and manufacturing site should reflect: (b)(4).Manufacturer's ref.No: (b)(4).

Event Description

It was reported that foot pedal did not get back in place immediately when the foot pedal was stopped during the ablation for pulmonary vein isolation procedure.The foot pedal got stuck and continued ablation, and stop button was used to stop ablation.When pressed foot pedal again, ablation started as usual.The procedure was completed without using foot pedal.The ablation was conducted by the remote of the stokert.The procedure was successfully completed without patient's consequence.This is mdr reportable as it posed potential risk for patient injury.

Manufacturer Narrative

Method - actual device evaluated - (b)(4).Results - friction problem -(b)(4) - a device problem caused by its surface coming in contact with another surface or fluid.Conclusion - device difficult to operate - (b)(4).Device problems including set-up, operation, and disassembly of equipment.(b)(4).It was reported that the foot pedal did not get back in place immediately when the foot pedal was stopped to be stomped during the ablation for pvi.The pedal was got back after a while.At that time the ablation was stopped.The procedure was completed without using the foot pedal.The ablation was conducted by the remote of the j70.The device was evaluated and foot pedal mechanical was defective.  foot pedal was replaced.Issue was resolved.The device was also subjected to pm, safety and functional testing and all tests passed.

Manufacturer Narrative

Manufacturing date for (b)(4) is november 2012.This stockert was manufactured before september 24, 2014, therefore no udi is applicable for this product with serial number (b)(4).

• 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 ; 9497893837
• MDR Report Key: 5494169
• MDR Text Key: 40414616
• Report Number: 9612355-2016-00015
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/02/2016

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-5463-320
• Device Catalogue Number: S7036
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/01/2016
• Initial Date FDA Received: 03/10/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 06/24/2016; 06/24/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/30/2012
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1