MAUDE Adverse Event Report: ERBE ELEKTROMEDIZIN GMBH ERBE VIO 100 C; ELECTROSURGICAL UNIT

Model Number VIO 100 C

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Burn(s) (1757)

Event Date 02/27/2024

Event Type  Injury  

Manufacturer Narrative

The esu was thoroughly inspected/tested and the bipolar cable was checked (note: since the forceps 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 esu.The bipolar cable was without defects.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 alternate site burn was due to the forceps being laid down onto the patient's arm and then, in the auto start mode it activated.This scenario is also supported by the elongated and narrow shape of the skin defect.There is a warning in the esu's user manual addressing this type of issue to avoid unintentional activations/burns.Instruments not being used must be "in a safe place: sterile, dry, non-conductive, and easy to see.Instruments that have been put down must not come into contact with the patient, medical personnel, or combustible materials.Instruments that have been put down must not come into contact with the patient, not even indirectly.An instrument can come into contact with the patient indirectly through electrically conductive objects or wet drapes, for example." however, no conclusive determination could be made as to the exact cause(s) of the event.No trends have been identified and erbe usa, inc.Is now closing the file on this incident.

Event Description

It was reported that a patient incident occurred with the electrosurgical unit (esu/generator) during the removal of a carpal boss.The esu was used with forceps from micromed [part number (p/n) 140-101-015, lot number (l/n) 0820] and an erbe bipolar cable (p/n 20196-055, l/n 10/21).No information was provided regarding the esu settings used in the operation.During or upon the intraoperative ablation of the carpal boss on the patient's left hand, a skin lesion was discovered on the front of the patient's left arm.Therefore, the necrosis was removed, and the site was bandaged.A photograph, presumably taken after the lesion was removed revealed that whitish skin defect was irritation-free, elongated, and narrow.

• Brand Name: ERBE VIO 100 C
• 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: 19002749
• MDR Text Key: 338888820
• Report Number: 9610614-2024-00023
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K101108
• 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: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: VIO 100 C
• Device Catalogue Number: 10140-500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2024
• Date Manufacturer Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/14/2021
• 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: 44 YR
• Patient Sex: Female
• Patient Weight: 68 KG