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

Event Date 09/19/2023

Event Type  Injury  

Event Description

It was reported that a patient incident occurred with an electrosurgical unit (esu/generator).The esu was used in an ablation, diep, reduction mammaplasty, and sentinel lymphnode dissection procedure.The generator was used with a monopolar instrument as well as bipolar forceps (from sutter medical).Specific information involving the settings of the esu was not provided.While the monopolar instrument was being used, the bipolar forceps were placed on an abdominal cloth on the chest/neck area of the patient.After the procedure, medical personnel noticed a 2nd to 3rd degree burn of 2 cm x 1 cm in the cleavage/chest area of the patient.To address the issue, the wound was disinfected and treated with mepilex.

Manufacturer Narrative

The esu was inspected/tested (note: the involved accessories were not available for an examination.).The unit was found to be working 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 generator was/is within specifications and all features were/are functioning properly.In conclusion, no erbe equipment problem was found that would have caused or contributed to the incident.Based upon the limited information provided, it appears that the bipolar forceps that were placed on the patient (on the cloth which may have been damp) became unintentional activated (e.G., due to the auto-start function, whereby the forceps are activated as soon as the branches are in contact or touch conductive material).As a result, the burn occurred.The user manual of the electrosurgical unit explicitly warns against the unintentional activation or placing of hot instruments on the patient.The instruments must be stored in a safe place (sterile, dry, non-conductive, easily visible).However, no conclusive determination could be made as to the cause of the event.Erbe usa, inc.Is now closing the file on this event.

• 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: 17948540
• MDR Text Key: 325803987
• Report Number: 9610614-2023-00052
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K060484
• 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: 10/17/2023

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 300 D
• Device Catalogue Number: 10140-000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2023
• Initial Date Manufacturer Received: 09/22/2023
• Initial Date FDA Received: 10/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/22/2005
• 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: 51 YR
• Patient Sex: Female
• Patient Weight: 77 KG