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 Cardiac Arrest (1762)

Event Date 10/15/2020

Event Type  Injury  

Manufacturer Narrative

The equipment was not returned to erbe for an evaluation because it didn't malfunction.No anomalies were found in the review of the device history records (dhrs) for the units.In conclusion, there were no erbe equipment problems that would have caused or contributed to the reported event.There is a warning in the erbe esu and apc user manuals addressing this issue as follows: "interference with cardiac pacemakers, internal defibrillators, or other active implants activation of the electrosurgical unit may affect the performance of active implants or damage them.Risk of injury or death for patients! in the case of patients having active implants, consult the manufacturer of the implant or the competent department of your hospital prior to performing surgery.Do not position the neutral electrode near cardiac pacemakers, internal defibrillators, or other active implants." additionally, when the incident was reported, erbe's clinical education manager provided the account with position statements of recommended practices from several societies and authorities (asge, asa, etc.) involving patients with an aicd.To further address the issue, additional in-service work is being planned with the staff at the medical facility.No trends have been identified with this incident.Erbe usa, inc.Is now closing the file on this event.

Event Description

It was reported that a patient incident occurred with the electrosurgical unit (esu/generator).The esu was used with an argon plasma coagulator (apc, part number 10134-000, associated serial number (b)(4)) and an argon plasma coagulation probe.The patient underwent an upper endoscopy and they had to defibrillate the patient.Additionally, it was reported that the patient had an automatic implanted cardiac defibrillator (aicd).Per the provided information the patient was not injured.

• Brand Name: ERBE VIO 300 D
• Type of Device: ELECTROSURGICAL UNIT
• Manufacturer (Section D): ERBE ELEKTROMEDIZIN GMBH; waldhornlestrasse; tubingen 72072 ; GM
• Manufacturer (Section G): ERBE ELEKTROMEDIZIN GMBH; waldhornlestrasse; tubingen 72072 ; GM
• Manufacturer Contact: john tartal ; 2225 northwest parkway; marietta, GA 30067-9317 ; 7709554400
• MDR Report Key: 11313068
• MDR Text Key: 232155904
• Report Number: 9610614-2021-00003
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083452
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/11/2021

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: VIO 300 D
• Device Catalogue Number: 10140-100
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/18/2021
• Initial Date FDA Received: 02/11/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/20/2010
• 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): Life Threatening; Required Intervention
• Patient Age: 50 YR