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

Model Number VIO 200 S

Device Problem Output Problem (3005)

Patient Problem Bowel Perforation (2668)

Event Date 05/31/2019

Event Type  Injury  

Manufacturer Narrative

The electrosurgical unit (esu) has not yet been returned to erbe for an evaluation (note: there were no reported problems with the esu during the procedure.).No anomalies were found in the device history record (dhr) of the involved device.Most likely, there were many factors involved in the reported event.Notable factors involved the patient's disease state (i.E., having multiple large polyps in the right colon, a very thin walled area).Therefore, it appears that during or upon the required intervention work to remove the large polyps, the remaining tissue of the bowel wall did not stay intact which resulted in the perforated colon.However, no conclusive determination could be made as to the cause of the incident.If there are any issues with the esu upon an inspection/testing that could have caused or contributed to the reported event, a follow-up report will be filed.

Event Description

It was reported that a patient incident occurred with the electrosurgical unit (esu/generator).The esu was used in a colonoscopy to remove multiple large polyps in the right colon.A perforated colon was detected at the site.Therefore, the patient was taken to surgery where a successful colon resection was performed.From all reports, patient is doing well (note: physicians felt he used appropriate settings and technique.).

Manufacturer Narrative

The esu was thoroughly inspected/tested.The unit was found to be functioning as intended.The evaluation included an electrical safety check, a function 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 (note: unrelated to the reported incident, some routine service work was performed on the esu).Finally, no anomalies were found in the device history record (dhr) of the involved device.In conclusion, no equipment problem was found that would have caused or contributed to the event.Most likely, there were many factors involved in the reported event.Notable factors involved the patient's disease state (i.E., having multiple large polyps in the right colon, a very thin walled area).Therefore, it appears that during or upon the required intervention work to remove the large polyps, the remaining tissue of the bowel wall did not stay intact which resulted in the perforated colon.However, no conclusive determination could be made as to the cause of the incident.The account is being made aware of the findings.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 esu was used in a colonoscopy to remove multiple large polyps in the right colon.A perforated colon was detected at the site.Therefore, the patient was taken to surgery where a successful colon resection was performed.From all reports, patient is doing well (note: physicians felt he used appropriate settings and technique).

• Brand Name: ERBE VIO 200 S
• Type of Device: ELECTROSURGICAL UNIT
• Manufacturer (Section D): ERBE ELEKTROMEDIZIN GMBH; waldhornlestrasse; tubingen 72072 ; GM
• MDR Report Key: 8764266
• MDR Text Key: 150137760
• Report Number: 9610614-2019-00017
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• PMA/PMN Number: K080715
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 07/12/2019
• Device Age: 3 YR
• Initial Date Manufacturer Received: 06/06/2019
• Initial Date FDA Received: 07/05/2019
• Supplement Dates Manufacturer Received: 06/06/2019
• Supplement Dates FDA Received: 07/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 70 YR