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 08/28/2023

Event Type  Injury  

Event Description

It was reported that a patient incident occurred with an electrosurgical unit (esu/generator).The account didn't know which esu was used in the procedure [note: it could also have been esu model vio 3, part number (p/n): 10160-000, serial number: (b)(6)].Nevertheless, one of the generators was used to remove a testicular tumor.The esu was used with an erbe slim line electrode handle [p/n: 20190-067, lot number (l/n): information not provided (ni)] and bipolar forceps (manufacturer information: ni).A neutral electrode from the asmuth company (p/n: asne02, l/n: ni) was attached to the left thigh of the patient.Specific information involving the settings of the esu was not provided.During the procedure, a 5 cm2 burn (redness, blistering) occurred in the right groin of the patient.The wound was cooled and dressed.Further medical intervention was not needed, and the hospital stay was not prolonged.

Manufacturer Narrative

Both esus from the account were inspected/tested (note: the involved instruments and accessory were not made available for an examination.).The units were found to be working as intended.The evaluation of each included an electrical safety check, a functional check of each of the equipment's features and a power output check.The generators were/are within specifications and all features were/are functioning properly.In addition, no anomalies were found in the device history record (dhr) of either device.In conclusion, no erbe equipment problem was found that would have caused or contributed to the incident.Based upon the limited information provided, most likely the burn/necrosis was caused by leakage current.Presumably, the patient's testicle was on a surgical drape that was wet from disinfectant and blood.Electricity may have leaked to the patient's skin via the drape and caused the necrosis.The possibility of hf leakage current in connection with wet cloth causing a burn is a warning in the esu's user manual.However, no conclusive determination could be made as to the cause of the event.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: 17754875
• MDR Text Key: 323488945
• Report Number: 9610614-2023-00049
• 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: 09/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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: 08/29/2023
• Initial Date Manufacturer Received: 08/28/2023
• Initial Date FDA Received: 09/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/08/2020
• 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): Required Intervention
• Patient Age: 25 YR
• Patient Sex: Male
• Patient Weight: 75 KG