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 Burn(s) (1757)

Event Date 02/20/2024

Event Type  Injury  

Manufacturer Narrative

The esu was returned and thoroughly inspected/tested.A technical safety check was performed on the unit.This included an electrical safety check, a function check of each of the equipment's features, and a power output check.All features were/are functioning properly within specifications on the device.In conclusion, no erbe equipment problem was found that would have caused or contributed to the event.Based upon the provided information, it appears that the activation of electrosurgical unit led to a flame and then combustion/deflagration in the patient's mouth area due to the presence of oxygen, anesthetic gas, and/or disinfectant at a combustible level.The esu's user manual warns that combustion-promoting gases such as oxygen represent a fire hazard for patients and staff and that combustion-promoting gases may not be used during operations in the head/thorax area or that they must be suctioned off before using electrosurgery.The oxygen-carrying tubes/endotracheal tubes must therefore also be checked for leaks.The manual also warns that that there is a risk of explosion for the patient and user if ignitable anesthetics are used during operations on the head or thorax and the anesthetics must be aspirated before using electrosurgery.Finally, per the user manual, flammable disinfectants can also pose a risk of fire and explosion, and these must have completely evaporated and/or not accumulate in recesses in the body before electrosurgery is used.No trends have been identified and erbe usa, inc.Is now closing the file on this event.

Event Description

It was reported that the electrosurgical unit (esu/generator) was involved in a patient incident.The esu was used as part of an excision with closure of a tracheal fistula after a tracheostomy.An erbe monopolar cable [part number (p/n) 20192-127, lot number (l/n) infomation not provided (ni)], an erbe electrode handle with 2 buttons (p/n 20190-045, l/n wo (b)(4)), an erbe knife electrode (p/n 21191-000, l/n wo (b)(4)) and an erbe neutral electrode cable (p/n 20194-077, l/n ni) were used with the generator (note: it was reported that the erbe accessories were functional and without defects.).Information regarding any other equipment or accessory used in the procedure was not provided.Also, no information was provided involving the generator's settings (e.G., mode, effect, etc.).During intubation anesthesia, the fistula was cut in a spindle-shaped manner and coagulated with electrosurgery.Then, suddenly a deflagration (i.E., combustion) occurred which caused the patient's oral cavity (i.E., mouth, throat, epiglottis) to be burned.The wound was immediately cooled with water and the patient was reintubated (note: the removed intubation tube was black.).No additional information was conveyed to erbe regarding the patient's condition.

• 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: 18845717
• MDR Text Key: 336990072
• Report Number: 9610614-2024-00018
• 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: 03/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2024
• 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: 02/23/2024
• Date Manufacturer Received: 02/20/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/19/2008
• 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: 59 YR
• Patient Sex: Female