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 Date 11/24/2022

Event Type  Injury  

Manufacturer Narrative

The involved equipment was seized by the judicial authorities and has not, at this time, been made available for inspection/testing.No anomalies were found in the review of the esu's device history record (dhr).If the generator is evaluated and problems are found that could have caused or contributed to the reported incident, a follow-up report will be filed.At this time, no conclusive determination can be made as to the cause of the event.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 an incident occurred with the electrosurgical unit (esu/generator) during a cardiovascular surgery (note: an erbe smoke evacuator unit was also being used.It is not a product distributed in the u.S.).No information was provided in regards with the esu's settings or any other involved equipment/accessory.While performing the procedure, a fire occurred.No details were provided as to the origin of the fire.Nevertheless, the flames were quickly extinguished and the surgery continued.Nonetheless, the patient did suffer a burn to the skin.However, the extent and severity of the necrosis was not conveyed to erbe.Additionally, no details were provided in regards to if or how the burn was treated.

• 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: 15976136
• MDR Text Key: 305421330
• Report Number: 9610614-2022-00046
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2022
• 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?: No
• Date Manufacturer Received: 12/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2021
• 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: 50 YR