MAUDE Adverse Event Report: ERBE ELEKTROMEDIZIN GMBH ERBE VIO 300 D; ELECTROSURGICAL UNIT

Model Number VIO 300 D

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bowel Perforation (2668)

Event Date 03/13/2018

Event Type  Injury  

Manufacturer Narrative

The patient incident occurred more than 2 years ago and the specific erbe esu used in the procedure could not be identified.Therefore, inspection/testing of the hospital's erbe equipment, at this time, would not be of value.Nevertheless, per a review of the service records, no issues were found with the hospital's equipment that could have caused or contributed to the reported event.Most likely, there were many factors involved in the reported incident.Therefore, no definitive determination as to what caused the event could be ascertained.Erbe usa inc.Is closing the file on this event.

Event Description

It was reported that a patient incident occurred with an electrosurgical unit (esu/generator) at the medical facility.No specific esu could be identified as the involved equipment.The other serial numbers that may been involved were (b)(4).An esu was used in an esophagogastroduodenoscopy (egd) to treat an arteriovenous malformation (avm) in the duodenum.The generator was used with a boston scientific gold probe.A perforation occurred and no further information involving the patient was provided.

• 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
• MDR Report Key: 10080660
• MDR Text Key: 191795161
• Report Number: 9610614-2020-00013
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060484
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2020
• 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: 10140-000
• Was Device Available for Evaluation?: Yes
• Device Age: 15 YR
• Date Manufacturer Received: 04/27/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2005
• 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): Other
• Patient Age: 50 YR