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

Model Number VIO 200 S

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Abdominal Pain (1685); Fever (1858); Internal Organ Perforation (1987)

Event Date 03/30/2023

Event Type  Injury  

Manufacturer Narrative

The involved esu was inspected/tested.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 provided information, the report of the patient complaining of pain during the procedure was most likely the result of low frequency currents.This is a known phenomenon in electrosurgery and occurs mostly with non-contact modalities or modes like endocut where there are alternating cutting and coagulation phases.A perforation is a rare but serious complication of a diagnostic ercp.A thermal injury (e.G., from hf-current) and/or mechanical injury (e.G., from the accessory) cannot be excluded as potential factors in the incident.However, no conclusive determination could be made as to the cause of the event.No trends have been identified and erbe usa, inc.Is now closing the file on this incident.

Event Description

It was reported that a patient incident occurred with the electrosurgical unit (esu/generator) during and after an endoscopic retrograde cholangiopancreatography (ercp).The esu was used with a cook sphincterotome (g34779) and a 3m neutral electrode.The neutral electrode was placed on the patient's right thigh.The esu mode endocut i was used.During the procedure, the patient experienced pain.The following day, the patient came back to the hospital with pain and a fever.A perforation was detected and surgery was performed to address the issue.The patient was then in the hospital for seven (7) days to recover.

• Brand Name: ERBE VIO 200 S
• 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: 16910389
• MDR Text Key: 314983176
• Report Number: 9610614-2023-00027
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K080715
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: VIO 200 S
• Device Catalogue Number: 10140-400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2023
• Date Manufacturer Received: 05/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/17/2012
• 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: 60 YR
• Patient Sex: Male