MAUDE Adverse Event Report: ERBE ELEKTROMEDIZIN GMBH ERBE VIO 200 D; ELECTROSURGICAL UNIT

Model Number VIO 200 D

Device Problem Output Problem (3005)

Patient Problems Hemorrhage/Bleeding (1888); Bowel Perforation (2668)

Event Date 08/31/2020

Event Type  Injury  

Manufacturer Narrative

The esu was thoroughly inspected/tested.The unit's monopolar socket was found to have been damaged.It appears that the damage was caused by a significant amount of external force applied to the socket.Therefore, the generator was serviced (i.E., repaired and tested).In addition, no anomalies were found in the device history record (dhr) of the involved device.Most likely, there were many factors involved with the reported event.The output from the unit may have been compromised (i.E., low, inconsistent, etc.) due to a poor electrical connection between the unit and attached instrument which would have been caused by the socket damage.Also, the intervention work was performed in a very thin walled area of the colon on a very large polyp.In addition, bleeding could have reduced visualization.As a result, 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.

Event Description

It was reported that a patient incident occurred with the electrosurgical unit (esu/generator).The esu was used in a colonoscopy to remove a very large polyp in the cecum.Information regarding the accessories and settings used during the procedure was not provided.The target tissue area was lifted by saline.During the intervention work, the physician experienced difficulty cutting and hemostasis was insufficient.Approximately 12 hours after the first colonoscopy, a second colonoscopy was performed to address bleeding.During the manipulation of the scope, a perforation to the cecum occurred.An additional surgery was required to address the perforation.The esu was distributed to a hospital in (b)(6).

• Brand Name: ERBE VIO 200 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: 10641408
• MDR Text Key: 210272396
• Report Number: 9610614-2020-00035
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K080715
• 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: 10/07/2020

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?: Yes
• Device Operator: Health Professional
• Device Model Number: VIO 200 D
• Device Catalogue Number: 10140-200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2020
• Initial Date Manufacturer Received: 09/11/2020
• Initial Date FDA Received: 10/07/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/09/2016
• 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