MAUDE Adverse Event Report: ERBE ELEKTROMEDIZIN GMBH ERBE; ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES

Model Number 10140-100

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 11/21/2023

Event Type  malfunction  

Event Description

This erbe vio 300d electrosurgical generator was used for cautery for a pediatric surgery procedure this was facilitated in an operating suite that normally is utilized for neurosurgery surgical procedures.The room was utilized due to it being available to use.This erbe vio 300d is a device that normally would be used in specialty areas like neurosurgery and endoscopy procedures.Selections on the display screen for pre-loaded programs included on this device were "basic program" and "neuro program." the basic program is a factory set program that when selected by the operator using the device uses settings that the manufacturer sets as a factory default.It is used as a template to program other configurable settings like for neurosurgery program that was already configured on this device.The operator of the device using it, would have to select a program to use and then adjust the wattage output settings accordingly to operate.The system does not just initiate directly to a program, it has to be selected and confirmed by the operator of the device in order for it to provide therapy output to the handpiece.In this case, according to the documentation that was provided on this event report, the circulator confirmed the settings on the device, immediately after it was noted that the settings were high but by then the handpiece was energized causing an arc due to the high setting which attributed to the burn on the patient.The machine was sent back to erbe for evaluation and a loaner was provided.It was discovered after talking to erbe that the basic program settings could be adjusted for use however could not be adjusted to a lower level then saved as a default for use.Erbe, the manufacturer, stated that the "basic program" is factory set and used as a template to setup for new procedure settings to program.Clinical engineering contacted erbe on multiple occasions to ask if we could adjust the basic program to a lower level to mitigate any further risk.Unfortunately, they stated that it could not be done and that their safety feature of having the operator of the device confirm program is a sufficient safety feature.If the operator of the device attempts to use the device by energizing the handpiece or foot pedal for the handpiece without selecting a program, a pop up message "check program settings" will appear on the display screen and not allow for the device to provide and output to the handpiece to be used on the patient.They state that anyone who uses the device should adhere to the settings before use.However, i will be submitting a medsun report soon along with documentation in hopes that they can come to a resolution.With it possibly being a software change to the machine in order to change or hide this basic program setting manufacturer response for electrosurgical, cutting coagulation accessories, erbe (per site reporter).Erbe, the manufacturer, stated that the ¿basic program¿ is factory set and used as a template to setup for new procedure settings to program.

• Brand Name: ERBE
• Type of Device: ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES
• Manufacturer (Section D): ERBE ELEKTROMEDIZIN GMBH; 2225 northwest pkwy; marietta GA 30067
• MDR Report Key: 18737893
• MDR Text Key: 335738648
• Report Number: 18737893
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/08/2024,01/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 10140-100
• Device Catalogue Number: 10140-100
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/08/2024
• Event Location: Hospital
• Date Report to Manufacturer: 02/20/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 8 MO
• Patient Sex: Male
• Patient Weight: 8 KG