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

Model Number M-5463-01

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Pain (1994); Swelling (2091); Partial thickness (Second Degree) Burn (2694)

Event Date 02/25/2015

Event Type  Injury  

Event Description

It was reported that a patient underwent an atrial flutter procedure with a stockert 70 rf generator and a skin burn was noticed as the patient complained of back pain.The nurse inspected the area and noticed blistering on the patient's back.There is no further information about the hospitalization and if any additional intervention was performed.The patient¿s medical history is unknown.The patient was reported to be in stable condition at the time the complaint was reported.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.This event is being reported because skin burn with blistering it is considered to be second degree skin burn.

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.We have searched and found that this stockert was manufactured before september 24, 2014, therefore udi # is not applicable for this product with serial number (b)(4).Concomitant bwi products used: product name: carto® 3 system: us catalog #: fg540000, serial #:(b)(4); product name: coolflow® irrigation pump: us catalog #: cfp002, serial #: (b)(4); product name: bidirectional cs catheter: us catalog #: unknown, lot #: unknown; product name: thermocool catheter: us catalog #: unknown, lot #: unknown.(b)(4).

Manufacturer Narrative

Manufacturer¿s reference #: (b)(4).It was reported that a patient underwent an atrial flutter procedure with a stockert 70 rf generator and a skin burn was noticed as the patient complained of back pain.The nurse inspected the area and noticed blistering on the patient's back.There is no further information about the hospitalization and if any additional intervention was performed.The patient¿s medical history is unknown.The patient was reported to be in stable condition at the time the complaint was reported.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.This event is being reported because skin burn with blistering it is considered to be second degree skin burn.The investigational analysis has been completed.The device was evaluated and no error found.Device is within specification.During pm, it was found that old revision was on measurement board.Replace the measurement board.The device was subjected to pm, safety and functional testing and all tests passed.No malfunction found on device.The dhr review verifies that the device was manufactured in accordance with documented specification and procedures.Old revision on measurement board does not contribute to skin burn.

• 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 ; 9098398483
• MDR Report Key: 4614733
• MDR Text Key: 5653807
• Report Number: 9612355-2015-00013
• 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: 02/25/2015

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
• Other Device ID Number: (1)4260166370195
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/25/2015
• Initial Date FDA Received: 03/18/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening