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 03/26/2021

Event Type  Injury  

Manufacturer Narrative

The apc/esu system was returned and thoroughly inspected/tested.The apc/esu system was returned and thoroughly inspected/tested.A review of the chronological data at the time of the event didn't show that there were any equipment problems during the procedure.Then, a technical safety check was performed on each unit.This included an electrical safety check, a function check of each of the equipment's features, and a power output check.Also, the gas flow rates were measured and found to be within their acceptable ranges for the apc.All features were/are functioning properly within specifications on both devices [note: unrelated to the reported issue, the esu was updated to the software version (b)(4).This is typical routine service work.].In addition, no anomalies were found in the device history records (dhrs) for the apc and esu.In conclusion, no erbe 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, as reported the patient's condition of being high risk for the interventional work was a significant factor in the event.Nevertheless, upon the intervention, the remaining tissue of the bowl did not stay intact which resulted in the perforation.The account is being made aware of the findings.To further address the issue, additional in-service work was offered to the medical staff at the hospital; however, it was declined as they are very experienced users.No trends have been identified.Erbe usa, inc.Is now closing the file on this event.

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 a colonoscopy.The apc/esu system was used with a filter integrated argon plasma coagulation (fiapc) probe.The equipment settings were pusled apc mode, effect 2, 20 watts, 0.5 liters per minute (lpm) flow rate.Per the account, the patient was high risk for the interventional work.Specifically, patient had multiple comorbidities like strictures, being very elderly, etc.Upon the interventional work a perforation occurred.To address the issue, surgery was performed to close the perforation.

• Brand Name: ERBE APC 2
• Type of Device: ARGON PLASMA COAGULATOR
• 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 30067-9317 ; 7709554400
• MDR Report Key: 11694030
• MDR Text Key: 257216986
• Report Number: 9610614-2021-00006
• 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: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/20/2021

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: APC 2
• Device Catalogue Number: 10134-000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/31/2021
• Initial Date FDA Received: 04/20/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/14/2015
• 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: 89 YR