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

Model Number VIO 200 S

Device Problem Energy Output Problem (1431)

Patient Problem Bowel Perforation (2668)

Event Date 06/15/2020

Event Type  Injury  

Manufacturer Narrative

The esu was returned and thoroughly inspected/tested.Simulated testing with an active cord and snare wire demonstrated that the unit was/is functioning as intended (i.E., output energy was delivered to the instrument.).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.Based upon the findings, no equipment problem was found that would have caused or contributed to the event.Most likely, there were many factors involved in the reported incident.Specifically, upon the intervention, the remaining tissue of the bowl did not stay intact which resulted in the perforation.In conclusion, no determination could be made as to the cause of the event.The involved medical personnel are being made aware of the findings.To further address the issue, additional in-service work will be offered to the medical staff at the hospital.No trends have been identified and 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).The account stated "colonoscopy submucosal injection and polypectomy with snare.When it came time to recect polyp it didn't seem like they were getting power.They turn unit off and then on and it did work.They applied two clips.Patient came back and a small perforation was seen.Ruth said she thought they were going to do a colon resection but then said that may not have happened.Later dr (b)(6) said that he doesn't think it was our unit but wanted the unit checked out.(b)(6) from biomed said he checked the out puts and they were all could.".

• Brand Name: ERBE VIO 200 S
• 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: 10244687
• MDR Text Key: 197969507
• Report Number: 9610614-2020-00021
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080715
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 07/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2020
• 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: 06/29/2020
• Is the Reporter a Health Professional?: Yes
• Device Age: 1 YR
• Date Manufacturer Received: 06/19/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/27/2018
• 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