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 07/09/2019

Event Type  Injury  

Manufacturer Narrative

The electrosurgical unit (esu) was deemed by the customer to have functioned properly; therefore, the unit was not returned to erbe for an evaluation.No anomalies were found in the device history record (dhr) of the involved device.In conclusion, no equipment problem occurred that would have caused or contributed to the reported event.Most likely, there were many factors involved in the reported incident.However, the patient's condition of having a polyp in the ascending/cecum (i.E., a very thin-walled area) and it being on a fold were important anatomical aspects of the case (i.E., a difficult procedure).Nevertheless, no definitive determination as to what cause the event could be ascertained.The involved medical personnel are being made aware of the findings.Per the account, no additional in-service work is needed.Therefore, erbe usa inc.Is 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 a polyp on a fold in the ascending/cecum.The generator was used with a boston scientific snare wire.The unit's settings were endocut q, effect 2 and forced coag, effect 2, 15 watts.A cold snare wire technique was used to remove the polyp and bleeding occurred.The tip of the snare was then used with diathermy (forced coag) to stop the bleeding, but a small perforation occurred.Therefore to address the issue, the colon was re-sectioned.

• Brand Name: ERBE VIO 200 S
• Type of Device: ELECTROSURGICAL UNIT
• Manufacturer (Section D): ERBE ELEKTROMEDIZIN GMBH; waldhornlestrasse; GM
• Manufacturer (Section G): ERBE ELEKTROMEDIZIN GMBH; waldhornlestrasse; GM
• Manufacturer Contact: john tartal ; 2225 northwest parkway; marietta, GA 30067-9317
• MDR Report Key: 8804362
• MDR Text Key: 151496721
• Report Number: 9610614-2019-00018
• 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,health
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 07/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2019
• 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?: Yes
• Device Age: 3 YR
• Date Manufacturer Received: 07/11/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/15/2015
• 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: 76 YR