MAUDE Adverse Event Report: ERBE ELEKTROMEDIZIN GMBH ERBE VIO 200 D; ELECTROSURGICAL UNIT

Model Number VIO 200 D

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 02/04/2024

Event Type  Injury  

Event Description

It was reported that a patient incident occurred with the electrosurgical unit (esu/generator) during an endoscopic mucosal resection (emr).The esu was used with some other erbe equipment, but they were not a factor in the reported event.A neutral electrode [part number (p/n) information not provided (ni), lot number (l/n) ni]) was used with the generator.The neutral electrode was attached to the patient's right lower/middle abdomen.No information was provided regarding any other accessories used or the unit's settings.Upon the procedure, a skin lesion (burn/necrosis) was found under the neutral electrode.Per a provided photograph, there were three (3) small 2nd degree burns with surrounding redness on the right obese middle/lower abdomen.Erbe was not informed of any treatment administered to the patient to address the necrosis.

Manufacturer Narrative

The involved esu was returned and inspected/tested.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.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 may have become partially detached from the patient during the surgery, the neutral electrode may not have been compatibility with the esu and therefore not being monitored, etc.Based upon the limited information provided, the lesion was mostly a thermal burn (although an allergy reaction cannot be ruled).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.

• Brand Name: ERBE VIO 200 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: 18864829
• MDR Text Key: 337191957
• Report Number: 9610614-2024-00020
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 03/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: VIO 200 D
• Device Catalogue Number: 10140-200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/29/2024
• Date Manufacturer Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/14/2020
• 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: 41 YR
• Patient Sex: Male
• Patient Weight: 73 KG