MAUDE Adverse Event Report: STOCKERT GMBH STOCKERT 70 RF GENERATOR; SIMILAR DEVICE S7001, PMA # P990071

Model Number M-5463-02

Device Problems Mechanical Problem (1384); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/21/2014

Event Type  malfunction  

Event Description

It was reported that during an atrial ablation procedure using a stockert 70 rf generator, the foot pedal that is used to deliver radio frequency became stuck.The pedal did not return to the initial position.The customer reports that they confirmed that the screw of the spring of the foot switch had come off.The user was able to start and stop ablation using a remote control.The procedure was finished successfully and no adverse patient consequences were reported.Due to the potential risk to patient when a foot pedal is stuck, this event is mdr reportable.

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Concomitant products: unk.(b)(4).

Manufacturer Narrative

(b)(4).It was reported that during an ablation procedure using a stockert 70 rf generator, the foot pedal that is used to deliver radio frequency became stuck.The bwi investigational analysis has been completed.The complaint device was found to have a missing screw, the screw of the spring on the foot switch had come off.The screw has been replaced.The system is now working fine.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: 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-79 111; GM D-79111
• Manufacturer Contact: jaime chavez ; 9098398483
• MDR Report Key: 4354202
• MDR Text Key: 5203175
• Report Number: 9612355-2014-00060
• Device Sequence Number: 1
• Product Code: DRF
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/01/2014

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-5463-02
• Device Catalogue Number: S7002
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/28/2014
• Initial Date FDA Received: 12/22/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/28/2015
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1