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 Partial thickness (Second Degree) Burn (2694)

Event Date 10/23/2023

Event Type  Injury  

Manufacturer Narrative

The esu was thoroughly inspected/tested.A technical safety check was performed on the generator.This included an electrical safety check, a functional check of each of the equipment's features, and a power output check.All features were/are functioning properly within specifications for the device.No anomalies were found in the review of the unit's device history record (dhr).In conclusion, no equipment problem was found that would have caused or contributed to the event.Based upon the provided information, the burn could have been due to the disinfectant being used and/or an unintentional contact with the monopolar electrode.Both of the potential issues are addressed as warnings in the erbe esu user manual.No trends have been identified with this incident.Erbe usa, inc.Is now closing the file on this event.

Event Description

It was reported that a patient incident occurred with the electrosurgical unit (esu/generator) during an inguinal hernia operation.The esu was used with a monopolar electrode handle (manufacturer unknown).A megadyne neutral electrode (ne) from ethicon was placed under the patient.).Information regarding the esu settings employed was not provided.Upon or after cutting the subcutaneous tissue and coagulating small blood vessels, a 2nd degree burn (whitish in color with blistering) of 1 cm x 1.5 cm was observed next to the incision site.To address the issue, the area was cooled and a wound dressing was applied.

• 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: 18083432
• MDR Text Key: 327512249
• Report Number: 9610614-2023-00053
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: PL
• 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: 11/07/2023

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: 10140-100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2023
• Initial Date Manufacturer Received: 10/31/2023
• Initial Date FDA Received: 11/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/07/2013
• 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: 24 MO
• Patient Sex: Female
• Patient Weight: 20 KG