MAUDE Adverse Event Report: STOCKERT GMBH STOCKERT 70 RF GENERATOR; RADIOFREQUENCY GENERATOR AND ACCESSORIES/ACCESSORY CABLE

Model Number M-5463-01

Device Problems Device Dislodged or Dislocated (2923); Moisture or Humidity Problem (2986)

Patient Problem Burn(s) (1757)

Event Date 07/18/2014

Event Type  Injury  

Event Description

It was reported that during an ablation procedure, the patient voided the bladder on the procedure table and the grounding pad to the stockert 70 was soaked in urine.Several ablations took place until the issue was noticed.The grounding pad was replaced and the issue was resolved.No injury to the patient is noted.Upon following up with the customer, bwi received additional information which is now indicative of a reportable event.It was stated at end of an afib case noted that ablation pad had become dislodged and caused burn to lower back.Plastics surgery consulted on arrival to recovery area.The causality of adverse event was possibly device related.The size of the indifferent electrode used during the case was 9¿.The location of the indifferent electrode was lower back posterior to left scapula.Multiple attempts were done to request for further details.However no additional information has been provided.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).It was reported that during an ablation procedure, the patient voided the bladder on the procedure table and the grounding pad to the stockert 70 was soaked in urine.Several ablations took place until the issue was noticed.The grounding pad was replaced and the issue was resolved.No injury to the patient is noted.It was stated at end of an afib case noted that ablation pad had become dislodged and caused burn to lower back.Plastics surgery consulted on arrival to recovery area.The issue was not duplicated.The device was evaluated.Nis and ecg board were found defected during pm.Defected parts were replaced.Ep cooler was also upgraded.The device was subjected to the preventive maintenance, safety and functional testing and all tests passed.The defected parts were not contributed to adverse event.The device history record was reviewed and no anomalies were found related to this complaint.In addition, the 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-79 111; GM D-79111
• Manufacturer Contact: jaime chavez ; 15715 arrow hwy; irwindale, CA 91706 ; 9098398483
• MDR Report Key: 3999799
• MDR Text Key: 4777974
• Report Number: 9612355-2014-00037
• 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: 07/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 07/23/2014
• Initial Date FDA Received: 08/11/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/28/2014
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention