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 01/02/2024

Event Type  Injury  

Event Description

It was reported that a patient incident occurred with the electrosurgical unit (esu/generator) during a hip implantation on the right side.The esu was used with an erbe nessy omega neutral electrode (also referred to as a return electrode, patient pad, etc.) [part number: 20193-082, lot number: 231012-0817].The neutral electrode was placed on the patient's left lower abdomen.No information was provided regarding any of the other accessories used in the operation.Also, the esu settings used were not provided.When removing the return electrode, a skin lesion was found underneath it.The skin lesion was red in the shape or size of the outer ring of the neutral electrode with a blistering in an abdominal fold.Additionally, the tissue necrosis was where the patient pad was sticking to the patient.A photograph of the skin lesion confirmed the reported information.To address the burn/necrosis, a local dressing (allevyn plaster and fatty gauze, plaster) was applied.

Manufacturer Narrative

The esu was thoroughly inspected/tested (note: the involved erbe nessy omega neutral electrode was not returned for an examination.).The generator 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 unit was/is within specifications and all features were/are working properly.Finally, 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.Most likely, there were many factors involved with the reported event.However, an evaluation of the chronological data from the esu at the time of the incident revealed that the activations were energy intensive with many activations close to the power limit in the corresponding setting.There was relevant nessy symmetry warning messages regarding the neutral electrode as well as current density warning messages involving the return electrode.These messages indicated a potential rise in temperature under the patient pad.Based upon the provided information, it appears that the pad wasn't in full contact with the patient's skin (note: it was on a fold in the abdomen and presumably the tissue was fatty.).With the high settings in combination with the partial contact of the neutral electrode to the patient's skin, the current/heat was not sufficiently dispersed by the neutral electrode which resulted in the burn/necrosis.However, no conclusive determination could be made as to the cause of the incident.Nevertheless, warnings in the esu's user manual and neutral electrode's notes on use address the risk of pad burns and provide mitigation measures to minimize the possibility of burns.No trends have been identified and 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: 18542777
• MDR Text Key: 333236947
• Report Number: 9610614-2024-00005
• 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: 01/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2024
• 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: 01/11/2024
• Date Manufacturer Received: 01/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/10/2000
• 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: 53 YR
• Patient Sex: Male
• Patient Weight: 144 KG