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 Partial thickness (Second Degree) Burn (2694)

Event Date 02/19/2024

Event Type  Injury  

Manufacturer Narrative

The involved esu was returned and inspected/tested (note: since the neutral electrode was from another manufacturer, it was not available for an evaluation by erbe.Therefore, an assessment of the accessories' safety and functionality is unknown to us.).The unit 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 generator was/is within specifications and all features were/are functioning properly (note: an evaluation of the esu's chronological data revealed that during procedure the unit displayed symmetry warnings regarding the neutral electrode.).In addition, no anomalies were found in the device history record (dhr) of the device.In conclusion, no erbe equipment problem was found that would have caused or contributed to the incident.There are many possibilities as to the cause of the event.It could have been caused by 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, etc.(note: the esu was displaying warning messages involving the neutral electrode during the surgery.).Based upon the limited information provided, the lesion was mostly a thermal burn (although an allergy reaction cannot be ruled).However, the size of the skin lesion combined with this severity of the burn is very unusual for being a thermally induced necrosis.Nevertheless, there are many warnings in the unit's user manual addressing neutral electrode burns.Finally, no conclusive determination could be made as to the exact cause(s) of the incident.No trends have been identified and 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 a hip implantation procedure on the patient's left side.The esu was used with valleylab handle [part number (p/n) information not provided (ni), lot number (l/n) ni]) and a dual surface neutral electrode from skintact (p/n rsw 213/5, l/n 230821-0808).The neutral electrode was attached to the patient's right thigh.No information was provided regarding the unit's settings.Upon the procedure, a skin lesion (burn/necrosis) was found under the neutral electrode in a horseshoe-shape of approximate 200 cm² in size.Initially, the lesion was considered as a 1st degree burn, but over the course of a week it developed into a 2nd degree burn.Due to the necrosis, a skin transplant is being planned.

• 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: 18855357
• MDR Text Key: 337094373
• Report Number: 9610614-2024-00019
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2024
• 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: 03/04/2024
• Date Manufacturer Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/08/2019
• 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): Other
• Patient Age: 82 YR
• Patient Sex: Male
• Patient Weight: 88 KG