MAUDE Adverse Event Report: ERBE ELEKTROMEDIZIN GMBH ERBE ICC 200 E/A; ELECTROSURGICAL UNIT

Model Number ICC 200 E/A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Burn(s) (1757); Necrosis (1971)

Event Date 12/22/2023

Event Type  Injury  

Manufacturer Narrative

The esu was thoroughly inspected/tested.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.In conclusion, no erbe equipment problem was found that would have caused or contributed to the incident.The neutral electrode was not made available to erbe for an evaluation.Therefore, an assessment of the neutral electrode's safety and functionality is unknown to us.Based upon the limited information provided, there are many possibilities as to the cause of the incident.However, the fact that the skin lesion was not present immediately after the neutral electrode was removed suggests that it was not a thermal injury due to electrosurgery.Furthermore, the report of the skin lesion developing over time (i.E., during the week after the intervention) is more indicative of an allergic reaction at the neutral electrode site.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) postoperatively after an endoscopic argon plasma treatment for proctitis after radiation.The esu was used with a neutral electrode (information not provided).The neutral electrode was attached to the patient's right hip.No information was provided regarding any other accessories used or the settings of the equipment.A week after the procedure, the patient went to the hospital with a "bullous bladder" at the application site of the neutral electrode.The bubble developed over time and became a necrosis with a scab formation.Due to the skin lesion, the patient was hospitalized for inpatient treatment.

• Brand Name: ERBE ICC 200 E/A
• 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: 18776643
• MDR Text Key: 336188690
• Report Number: 9610614-2024-00015
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K933157
• 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: 02/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ICC 200 E/A
• Device Catalogue Number: 10128-036
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2024
• Initial Date Manufacturer Received: 01/31/2024
• Initial Date FDA Received: 02/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/21/2003
• 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): Hospitalization; Required Intervention
• Patient Age: 50 YR