MAUDE Adverse Event Report: ERBE ELEKTROMEDIZIN GMBH ERBE VIO 100 C; ELECTROSURGICAL UNIT

Model Number VIO 100 C

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Partial thickness (Second Degree) Burn (2694); Full thickness (Third Degree) Burn (2696)

Event Date 01/24/2024

Event Type  Injury  

Event Description

It was reported that a patient incident occurred with the electrosurgical unit (esu/generator) during/upon a reduction mammaplasty.The esu was used with an electrode handle from fiab [part number (p/n) (b)(4), lot number (l/n) 23ch1428] and a neutral electrode from emed (p/n (b)(4), l/n 21070).The neutral electrode was attached to the patient's left thigh.No information was provided regarding the esu settings used in the operation.However, according to the user, the esu did not achieve the desired effect without there being an alarm.Upon removing the neutral electrode after the procedure, a skin lesion/necrosis was found underneath it.The lesion was described as a 2nd to 3rd degree burn and covered approximately 5% of the neutral electrode's area.No information was provided as to how the burn was treated, but per the medical facility the patient's burn was treated.

Manufacturer Narrative

The esu was thoroughly inspected/tested.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 esu.In conclusion, no erbe equipment problem was found that would have caused or contributed to the incident.Since the accessories (including the neutral electrode) were from other manufacturers, they were not available for an evaluation by erbe.Therefore, an assessment of the accessories' safety and functionality is unknown to us.There are many possibilities as to the cause of the incident.It could have been an allergic reaction, a defect of the neutral electrode (i.E., the gel), incorrect preparation of the neutral electrode site or application of the neutral electrode, the esu's setting(s) being too high, activation time(s) being too long and/or the times between applications being too short which caused excessive heating under the neutral electrode, the neutral electrode became partially detached from the patient during use, the neutral electrode was not compatible with the esu and thus monitoring of the neutral electrode was lacking, etc.Based upon the limited information provided, no conclusive determination could be made as to the exact cause(s) of the event.No trends have been identified and erbe usa, inc.Is now closing the file on this incident.

• Brand Name: ERBE VIO 100 C
• 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: 18757208
• MDR Text Key: 335989787
• Report Number: 9610614-2024-00014
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K101108
• 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: 02/22/2024

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 100 C
• Device Catalogue Number: 10140-500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2024
• Initial Date Manufacturer Received: 01/26/2024
• Initial Date FDA Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/19/2019
• 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: Female
• Patient Weight: 75 KG