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 Bowel Perforation (2668)

Event Date 04/07/2022

Event Type  Injury  

Manufacturer Narrative

There is a plan to have the erbe equipment checked/evaluated at erbe usa.If any issues are found, a follow up report will be provided.No anomalies were found in device history record (dhr) of the involved device.Most likely, there were many factors involved in the event.At this time, no determination could be made as to the cause of the incident.

Event Description

It was reported that a patient incident occurred with the electrosurgical unit (esu/generator) during a colonoscopy to perform a polypectomy.The esu was used with a 13 mm boston snare.A description of the other accessories used in the procedure was not provided.The generator settings were as well as forced coag, effect 2, 20 watts and endocut q, settings 2, 1, and 6.Specifically, it was documented by the physician, dr.(b)(6), "during colonoscopy (i was doing the procedure), large polyp found on the hepatic flexure.Injected to lift polyp without issues.Once hot snare was used, the 'coag' pedal functioned appropriately but the 'cut' pedal did not.The tech was able to snare the polyp but it was done without the cut function.After the polyp was removed, a perforation was noted at the polypectomy site.This was successfully closed using clips, and the patient was admitted to the hospital for observation and antibiotics.This perforation likely occurred due to a device malfunction." no further information was provided in regards to the patient's condition.As a result of the incident, the medical center's clinical engineering department checked the unit.The esu passed their safety and performance test.

• 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: 14288418
• MDR Text Key: 290794731
• Report Number: 9610614-2022-00012
• 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: Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VIO 300 D
• Device Catalogue Number: 10140-100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/27/2018
• 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
• Patient Sex: Female