MAUDE Adverse Event Report: ERBE ELEKTROMEDIZIN GMBH ERBE VIO 200 S; ELECTROSURGICAL UNIT

Model Number VIO 200 S

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 06/05/2023

Event Type  Injury  

Event Description

It was reported that a patient incident occurred with the electrosurgical unit (esu/generator) during an endoscopic mucosa resection (emr).The esu was used with an erbe nessy omega neutral electrode (also referred to as a return electrode, patient pad, etc.) [part number: 20193-082, lot number: information not provided).The neutral electrode was placed on the patient's right lower leg.No information was provided regarding any of the other accessories used in the operation.Also, the esu settings used were not provided.When removing the return electrode, a skin lesion was found underneath it.Upon reviewing photographs of the necrosis and pad, it was black indicating a 3rd degree burn (note: also, there were two black discolorations on the neutral electrode.).The burn was treated with ointment.

Manufacturer Narrative

The esu was thoroughly inspected/tested (note: the involved erbe nessy omega neutral electrode was not returned for an examination.).The generator was found to be functioning as intended.The evaluation included an electrical safety check, a functional check of each of the equipment's features and a power output check.The unit was/is within specifications and all features were/are working properly.Finally, no anomalies were found in the device history record (dhr) of the involved device.In conclusion, no erbe equipment problem was found that would have caused or contributed to the incident.Most likely, there were many factors involved with the reported event.Based upon the provided information, it appears that the pad didn't come into full contact with the patient's skin in combination with a suspected short circuit between the equipotential ring and the neutral electrode surfaces.Therefore, the current/heat was not sufficiently dispersed by the neutral electrode which resulted in the necrosis.However, no conclusive determination could be made as to the cause of the incident.Nevertheless, warnings in the esu's user manual and neutral electrode's notes on use address the risk of pad burns and provide mitigation measures to minimize the possibility of burns.No trends have been identified and erbe usa, inc.Is now closing the file on this event.

• Brand Name: ERBE VIO 200 S
• 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: 17324282
• MDR Text Key: 319015269
• Report Number: 9610614-2023-00044
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K080715
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/14/2023

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: VIO 200 S
• Device Catalogue Number: 10140-400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2023
• Initial Date Manufacturer Received: 06/30/2023
• Initial Date FDA Received: 07/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/03/2020
• 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: 48 YR
• Patient Sex: Female
• Patient Weight: 50 KG