MAUDE Adverse Event Report: ERBE ELEKTROMEDIZIN GMBH ERBE VIO 300 D; ELECTROSURGICAL UNIT

Model Number VIO 300 D

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Paralysis (1997); Perforation (2001)

Event Date 04/07/2020

Event Type  Injury  

Manufacturer Narrative

The esu were thoroughly inspected/tested.The esu 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.Finally, no anomalies were found in the device history record (dhr) of the involved esu.In conclusion, no equipment problem was found that would have caused or contributed to the event.Most likely, there were many factors involved in the reported incident.However, the patient's disease state was most likely an important factor involved with the event.Nevertheless, no definitive determination as to what caused the incident could be ascertained.No trends have been identified and 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) during a video-assisted mediastinal lymphadenectomy (vamla) to treat bronchial carcinoma.During the procedure, lymph node biopsies were taken paratracheally from both sides.The mobilization and coagulation of the infracarinal lymph node resulted in ventral lesions of both the main bronchi with a covered perforation.The laryngeus recurrens nerve on both sides were paralysis and the patient had to be tracheotomized.The patient hospitalization was extended.The esu was distributed to a hospital in (b)(6).

• 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
• MDR Report Key: 10091415
• MDR Text Key: 192144826
• Report Number: 9610614-2020-00014
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K083452
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2020
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2020
• Device Age: 9 YR
• Date Manufacturer Received: 05/05/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/21/2010
• 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): Hospitalization; Required Intervention
• Patient Age: 68 YR
• Patient Weight: 92