MAUDE Adverse Event Report: ERBE ELEKTROMEDIZIN GMBH ERBE APC 2; ARGON PLASMA COAGULATOR

Model Number APC 2

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Bowel Perforation (2668)

Event Date 08/02/2022

Event Type  Injury  

Event Description

It was reported that an erbe system, argon plasma coagulator (apc)/electrosurgical unit (esu/generator, model vio 300 d, part number (p/n) 10140-100, serial number (b)(4)) system was involved in a patient incident upon an esophagogastroduodenoscopy (egd) and colonoscopy (patient had a history of anemia.).An apc probe was used in the procedures.Argon plasma coagulation was applied to address gastric, small bowel, and colonic arteriovenous malformations (avms).The patient was discharged from the hospital the same day.The next day, she was admitted at another hospital ((b)(6) hospital) and treated for a delayed perforation.A resection procedure was performed to remedy a perforation in the small bowel.

Manufacturer Narrative

There is a plan to have the erbe equipment checked/evaluated at erbe usa.If any issues are found, a follow up report will be provided.No anomalies were found in device history records (dhrs) of the involved devices.Most likely, there were many factors involved in the event.However, the patient's condition appears to have played a significant role in the incident.The patient is very old, has a history of anemia/indicating bleeding, has avms throughout gi tract (and especially in thin-walled areas), etc.Specifically, upon the intervention work, the remaining tissue of the small bowl did not stay intact which resulted in the perforation.Nevertheless, at this time, no determination could be made as to the cause of the incident.To further address the issue, additional in-service work is being planned at the account with the involved staff on 08/16/2022.No trends have been identified and erbe usa, inc.Is now closing the file on this event.

• Brand Name: ERBE APC 2
• Type of Device: ARGON PLASMA COAGULATOR
• 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: 15232047
• MDR Text Key: 297950900
• Report Number: 9610614-2022-00027
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K024047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: APC 2
• Device Catalogue Number: 10134-000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/10/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/23/2017
• 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: 87 YR
• Patient Sex: Female
• Patient Race: White