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 Problems Unspecified Infection (1930); Pain (1994); Pericardial Effusion (3271)

Event Date 10/07/2022

Event Type  Injury  

Event Description

It was reported that a patient incident occurred with the electrosurgical unit (esu/generator) during an endoscopic incision of intrathoracic esophagojejunal anastomosis.The esu was used with a monopolar needle knife from another manufacturer (mtw endoskie).Information regarding if a return electrode was used or type, placement, etc.Was not conveyed.Additionally, no information was provided in regards to the unit's settings.Nevertheless, postoperatively, the patient immediately complained of pain which increased over the course of days.Also, pericardiai effusion occurred and it became infected.The patient was monitored and treated in the icu (i.E., received pericardiai drainage, etc).Finally, the patient suffered ischemic liver damage.No further details were specified in regards to the patient's condition.

Manufacturer Narrative

The involved esu was inspected/tested [note: no information was provided in regards with any evaluation performed on the other company's accessory (i.E., the monopolar needle knife)].The unit 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 generator was/is within specifications and all features were/are functioning properly.In addition, 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.Based upon the lack of information provided (i.E., not knowing the exact location of the anastomosis in relation to the pericardium; modes/settings of the esu, etc.; cause of the pericardiai effusion, etc.), there are many possible scenarios that may have caused the event.Possibly, a perforation occurred at the incision site (via mechanically or thermally) which resulted in the patient's complications.However, no conclusive determination could be made as to the cause of the incident.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: 16245650
• MDR Text Key: 308156742
• Report Number: 9610614-2023-00005
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: 01/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2023
• Is this an Adverse Event Report?: Yes
• 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: 01/16/2023
• Date Manufacturer Received: 01/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/12/2021
• 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): Hospitalization; Required Intervention; Life Threatening
• Patient Age: 41 YR
• Patient Sex: Female
• Patient Weight: 61 KG