MAUDE Adverse Event Report: ERBE ELEKTROMEDIZIN GMBH ERBE VIO 300 D; ELECTROSURGICAL UNIT

Model Number VIO 300 D

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Burn(s) (1757)

Event Date 03/21/2024

Event Type  Injury  

Event Description

It was reported that a patient incident occurred with the electrosurgical unit (esu/generator) during a transurethral resection (tur) of the bladder to remove a tumor.The esu was used with a dahlhausen neutral electrode (also referred to as a return electrode, patient pad, etc.) [part number 19.000.02.605, lot number information not provided].The neutral electrode was placed on the patient's right thigh.No information was provided regarding any of the other accessories used in the operation.Also, the esu settings used were not provided.However, it was reported that due to not achieving the desired tissue effect, the power was manually increased.Additionally, according to the user, there were no warnings from the generator regarding the quality of the application of the neutral electrode.When removing the return electrode, a skin lesion was found underneath it.A photograph of the necrosis showed a semi-circular reddening approximately 1 cm wide.The photograph also revealed that the adhesive site of the neutral electrode was still very hairy and therefore the placement site had not been prepared.The burn was treated with ointment.

Manufacturer Narrative

The esu was thoroughly inspected/tested (note: since the involved neutral electrode was from another manufacturer, it was not available for an evaluation by erbe.Therefore, an assessment of the accessory's safety and functionality is unknown to us.).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.As part of the generator's assessment, the chronological data at the time of the operation was reviewed.The data revealed the following: 1.There were 25 activations during the procedure.2.The settings were auto cut, effect 4 at 180 watts and forced coag, effect 2 at 100 watts.3.Several activations were longer than 10 seconds.One of these activations was terminated by the device after 40 seconds.4.There were approximately 19 messages regarding the current density, which indicated that the neutral electrode current was above the permitted current density.The message is non-activation interrupting.Based upon the information provided, the lesion was most likely a thermal burn.However, other possible causes of the skin lesion couldn't be ruled out.In this case, the inadequately prepared application site of the neutral electrode, the high output settings, the long activations, etc.Combined with the warning messages from the unit regarding activation duration and current density are indicative of issues which would lead to a pad burn.That is, the current/heat was not sufficiently dispersed by the neutral electrode which resulted in the necrosis.However, no conclusive determination could be made as to the cause of the incident.Nevertheless, warnings in the esu's user manual 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 300 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: 19031165
• MDR Text Key: 339221513
• Report Number: 9610614-2024-00024
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 04/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: VIO 300 D
• Device Catalogue Number: 10140-100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2024
• Date Manufacturer Received: 03/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/29/2009
• 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: 63 YR
• Patient Sex: Male