MAUDE Adverse Event Report: ERBE ELEKTROMEDIZIN GMBH ERBE VIO 300 D; ELECTROSURGICAL UNIT

Model Number VIO 300 D

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Full thickness (Third Degree) Burn (2696)

Event Date 11/08/2022

Event Type  Injury  

Manufacturer Narrative

The esu was thoroughly inspected/tested (note: the non-erbe instrument was not made available for an evaluation.).A technical safety check was performed on the generator.This included an electrical safety check, a functional check of each of the equipment's features, and a power output check.All features were/are functioning properly within specifications for the device.No anomalies were found in the review of the unit's device history record (dhr).In conclusion, no erbe equipment problem was found that would have caused or contributed to the event.Based upon the provided information, several possible scenarios may have caused the fire: (1) the handle was unintentionally activate, (2) the handle was hot, (3) combustible/flammable medium (e.G.Disinfectant, etc.) was in the vicinity, and/or (4) the handle with cable was defective.Warnings in the esu's user manual expressly address the possible scenarios.Specifically, there is a risk of burns for the patient and medical staff due to unintentional activation of an instrument.Instruments should be placed in a safe place: sterile, dry, non-conductive, easily visible.Stored instruments must not come into contact with the patient, the medical staff and combustible materials.Instruments that have been put down must not touch the patient directly or indirectly.No trends have been identified with this incident.Erbe usa, inc.Is now closing the file on this event.

Event Description

It was reported that an incident occurred with the electrosurgical unit (esu/generator) while removing a blood clot in a patient's left iliacal artery.The esu was used with a medimex handpiece with cable (handpiece part number 8m900045, cable part number 8m920137).An erbe nessy return electrode was attached to the patient's right flank.No information was provided in regards with the esu's settings or other involved accessories.After hemostasis had been achieved, the handle was placed in a fold, formed by the sterile drape, between the patient's feet (outside of the surgical area).Then flames were observed in the area of the handle (note: it was not being used at this point in time.).The handle was removed from the area and disconnected.Upon examining the patient where the fire occurred, a 3rd degree burn was found on the inner edge of the patient's right foot.The necrosis was 0.5 cm x 1.5 cm with a yellow-brown border.To address the issue, the necrosis was removed intraoperatively and then the wound was treated with an antibacterial ointment dressing.

• Brand Name: ERBE VIO 300 D
• Type of Device: ELECTROSURGICAL UNIT
• Manufacturer (Section D): ERBE ELEKTROMEDIZIN GMBH; waldhornlestrasse 17; tubingen, germany 72072 ; GM 72072
• Manufacturer (Section G): ERBE ELEKTROMEDIZIN GMBH; waldhornlestrasse 17; tubingen, germany 72072 ; GM 72072
• Manufacturer Contact: john tartal ; 2225 northwest parkway; marietta, GA 30067-8764 ; 7709554400
• MDR Report Key: 15852260
• MDR Text Key: 304189468
• Report Number: 9610614-2022-00044
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K083452
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: VIO 300 D
• Device Catalogue Number: 10140-100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2022
• Date Manufacturer Received: 11/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/29/2019
• 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: 54 YR
• Patient Sex: Male
• Patient Weight: 83 KG