MAUDE Adverse Event Report: ERBE ELEKTROMEDIZIN GMBH ERBE VIO 3; ELECTROSURGICAL UNIT

Model Number VIO 3

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Burn(s) (1757)

Event Type  Injury  

Event Description

It was reported that a patient incident occurred with the electrosurgical unit (esu/generator) during an ablation of anal skin tags.No information was provided regarding the accessories used or the equipment's settings.Upon activation of the esu, a flame formed at the surgical site where disinfectants octenisept and kocan g were applied.This resulted in a burn to the patient's anus, testis, and rump.No information was conveyed as to the degree of the burn or if any medical treatment was provided to address the necrosis.

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.In addition, 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.Based upon the description of the event, most likely once diathermy was applied, combustion occurred due to flammable vapors and/or the remaining disinfectant that was around the operative site.There are warnings in the erbe esu user manual addressing these issues (i.E., not to use flammable disinfectants or if using a flammable disinfectant, it must be dry/completely evaporated prior to activation.).Additionally, the product data sheets for the octenisept and kocan g disinfectants used warns that the disinfectants are highly flammable, and the vapors can form explosive mixtures with air.No trends have been identified with this incident.Erbe usa, inc.Is now closing the file on this event.

• Brand Name: ERBE VIO 3
• 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: 17555749
• MDR Text Key: 321229687
• Report Number: 9610614-2023-00048
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K190823
• 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: 08/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: VIO 3
• Device Catalogue Number: 10160-000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2023
• Date Manufacturer Received: 07/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/06/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 30 YR
• Patient Sex: Male