MAUDE Adverse Event Report: ERBE ELEKTROMEDIZIN GMBH ERBE APC 3; ARGON PLASMA COAGULATOR

Model Number APC 3

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Internal Organ Perforation (1987)

Event Date 05/26/2022

Event Type  Injury  

Event Description

It was reported that an erbe system, argon plasma coagulator (apc)/electrosurgical unit (esu/generator, model vio 3, part number (p/n) 10160-000 (b)(4)) system was involved in a patient incident during an upper gastrointestinal procedure.The patient was being treated with argon plasma coagulation to control/stop bleeding in the patient's stomach.The apc/esu system was used with an fiapc straight fire, 2.3 mm probe (part number 20132-214).The equipment settings were pulsedapc mode, effect 2.5, 0.8 liter/minute flow rate.A perforation occurred and surgical intervention was required to address the issue.

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.At this time, no determination could be made as to the cause of the incident.

• Brand Name: ERBE APC 3
• 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: 14884693
• MDR Text Key: 295113967
• Report Number: 9610614-2022-00020
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191234
• 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: 07/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: APC 3
• Device Catalogue Number: 10135-000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/06/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/18/2021
• 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): Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female