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

Model Number APC 2

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bowel Perforation (2668)

Event Date 06/01/2020

Event Type  Injury  

Manufacturer Narrative

The customer did not return the equipment to erbe for an evaluation because they did not see that it was needed.No anomalies were found in the device history records (dhrs) of the involved devices.Most likely, there were many factors involved in the reported incident.However, the patient's condition in all likelihood was a key factor in the outcome.That is, having avms in the ascending colon, a thin-walled area of the bowel.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 was offered to the medical staff at the hospital.It is pending per the nurse manager gathering all information prior to planning another in-service /case support work.Erbe usa inc.Is now closing the file on this event.

Event Description

It was reported that an erbe system, argon plasma coagulator (apc) with an electrosurgical unit (esu/generator, model vio 300 d, part number (p/n) 10140-100, serial number (b)(4)) was involved in a patient incident.The apc/esu settings were pulsed apc, effect 2, 30 watts with a gas flow of 0.8 liters per minute.The system was used with an fiapc circumferential probe (part number 20132-218, lot number 141117) to treat arteriovenous malformations (avms) in the ascending colon.A micro perforation occurred; therefore, a laparoscopy 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
• MDR Report Key: 10183439
• MDR Text Key: 198343533
• Report Number: 9610614-2020-00018
• 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: Physician
• Type of Report: Initial
• Report Date: 06/23/2020

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Device Age: 3 YR
• Initial Date Manufacturer Received: 06/04/2020
• Initial Date FDA Received: 06/23/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/26/2015
• 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: 65 YR
• Patient Weight: 170