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

Model Number M-5463-01

Device Problem Insufficient Information (3190)

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

Event Date 03/10/2017

Event Type  Injury  

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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.This generator was manufactured before september 24, 2014, therefore no udi is applicable for this product with serial number (b)(4).Manufacturer's ref.No: (b)(4).

Event Description

It was reported that a patient underwent an ablation procedure for atrial flutter with a stockert 70 system and suffered burns second degree requiring ointment and bandages.When the grounding pad was removed, a blister was noticed on the patient¿s skin.Intervention was ointment and bandages.The patient was reported to be in stable condition at the time the complaint was reported.There is no information about the hospitalization.The physician did not provide a causality opinion for the cause of this adverse event.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.Since this adverse event required medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure, it is to be considered serious and mdr reportable.

Manufacturer Narrative

Additional information was provided on the event on (b)(6) 2017.The patient was a (b)(6)year old female patient.The patients date of birth is (b)(6) 1960.The patient¿s weight is (b)(6).The patient suffered burns second degree requiring a wound care consult with topical ointment and dressing.Patient did not require extended hospitalization as a result of the adverse event.The patient¿s condition improved and skin was healing at the time of follow-up appointment.Physician¿s opinion regarding the cause of the adverse event is that it was related to the grounding pad.(b)(4).

Manufacturer Narrative

(b)(4).It was reported that a (b)(6) year old female patient underwent an ablation procedure for atrial flutter with a stockert 70 system and suffered burns second degree requiring a wound care consult with topical ointment and dressing.When the grounding pad was removed, a blister was noticed on the patient¿s skin.Intervention was ointment and bandages.The patient was reported to be in stable condition at the time the complaint was reported.Patient did not require extended hospitalization as a result of the adverse event.The patient¿s condition improved and skin was healing at the time of follow-up appointment.Physician¿s opinion regarding the cause of the adverse event is that it was related to the grounding pad.Repair follow-up was performed and no responses from the customer.Service was declined.Complaint was unable to be confirmed.The device history record (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-791 11; GM D-79111
• Manufacturer Contact: joaquin kurz ; 33 technology drive; irvine, CA 92618 ; 9497893837
• MDR Report Key: 6452426
• MDR Text Key: 71464353
• Report Number: 9612355-2017-00021
• 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,Followup
• Report Date: 03/15/2017

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: 03/10/2017
• Initial Date FDA Received: 04/02/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 05/05/2017; 06/26/2017
• 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): Required Intervention
• Patient Age: 56 YR
• Patient Weight: 68