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 11/18/2022

Event Type  Injury  

Event Description

It was reported that a patient incident occurred with the electrosurgical unit (esu/generator) during an endoscopic retrograde cholangiopancreatography (ercp).No information was provided in regards to the accessories being used.The esu settings were endocut i, effect 2 cut duration 3, cut interval 3.A "zipper cut" (large cut with charring) occurred which resulted in a perforation.To address the issue, a laparotomy was performed to repair the duodenal perforation.Then, the patient was discharged and doing well (note: a week later, a different doctor reported that there was no endocut tone with a large cut and charring.But, no patient injury was reported.).

Manufacturer Narrative

The involved equipment is to be returned to erbe for an evaluation (i.E., inspection/testing).No anomalies were found in the review of the esu's device history record (dhr).If the generator is evaluated and problems are found that could have caused or contributed to the reported incident, a follow-up report will be filed.At this time, no conclusive determination can 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.

• Brand Name: ERBE VIO 300 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: 15995081
• MDR Text Key: 305591554
• Report Number: 9610614-2022-00048
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2022
• 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?: Yes
• Date Manufacturer Received: 11/29/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/03/2019
• 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): Required Intervention
• Patient Age: 44 YR
• Patient Sex: Male
• Patient Race: Asian