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

Model Number VIO 200 D

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Internal Organ Perforation (1987)

Event Date 11/20/2023

Event Type  Death  

Manufacturer Narrative

The esu was thoroughly inspected/tested.A technical safety check was performed on the generator.This included an electrical safety check, a functional check of each of the equipment's features, and a power output check.All features were/are functioning properly within specifications for the device.In addition, no anomalies were found in the device history record (dhr).In conclusion, no equipment problem was found that would have caused or contributed to the event.There were no reported equipment or accessory issues.Most likely there were many factors involved in the incident.Therefore, no conclusive determination could be made as to the cause of the event.No trends have been identified with this incident.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 an endoscopic retrograde cholangiopancreatography (ercp) with ampullectomy.The esu was used with snares (captivator snare) from boston scientific.The other accessories from erbe were a footswitch [part number (p/n): 20189-302, lot number: (l/n) wo266427], monopolar cable /a-cord [p/n: 20192-117, l/n: information not provided (ni)] and a neutral electrode cable (p/n: 20194-080, l/n: ni).A neutral electrode from skintact was attached to the patient's right thigh.According to the user, the settings on the esu were sphincterotomy: cut effect 2, forced coag effect 1, 20 watts [maximum (max.], right colon: cut effect 1, forced coag effect 1, 15 watts (max.), left colon: cut effect 3, forced coag effect 1, 30 watts (max.).During the procedure, a thermal injury/perforation occurred around the area of the ampullectomy.A ct scan showed retroperitoneal gas accumulation (i.E., a perforation).To address the perforation a second operation was performed.However, on (b)(6) 2023; the patient died.No information was provided as to the cause of the patient's death.

• Brand Name: ERBE VIO 200 D
• 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: 18435045
• MDR Text Key: 331779859
• Report Number: 9610614-2024-00001
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 12/11/2023
• Date Manufacturer Received: 12/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/29/2016
• 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): Death; Hospitalization; Required Intervention
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Weight: 86 KG