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 Problems Hemorrhage/Bleeding (1888); Ulcer (2274); Hematemesis (4478)

Event Date 01/09/2024

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, serial number (s/n) (b)(6)] system with a waterjet model erbejet 2 (p/n 10150-000, s/n (b)(6)) were involved in a patient incident after a gastric mucosa ablation (gma) as part of an hybridapc obesity study.The equipment was used with a hybridapc probe [p/n 20150-015, lot number (l/n) wo403073], waterjet pump cartridge (p/n 20150-301, l/n wo409593), and neutral electrode (nessy® plate 170, p/n 20193-074, l/n 210621-2401).The accessories were discarded after the procedure; therefore, they were not available for an examination.Approximately one (1) week after the gma treatment/procedure, the patient had upper gastrointestinal bleeding with melena and hematemesis as well as abdominal pain due to the formation of an ulcer.Then, the patient was admitted to the hospital for observation and treated with various medications (including acid­blocking medication).The patient was discharged four (4) days later.No surgery was performed due to the bleeding.

Manufacturer Narrative

The apc/esu system with the waterjet were thoroughly inspected/tested by rymed.A technical safety check was performed on each unit.This included an electrical safety check, a functional 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 the devices.Additionally, no anomalies were found in the device history records for the equipment or the hybridapc probe.In conclusion, no erbe equipment problem was found that would have caused or contributed to the event.Per the study protocol, ulcer formation with bleeding is considered as an anticipated adverse device effect (ade) associated with gma.Erbe usa, inc.Is now closing the file on this event.

• 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: 18586393
• MDR Text Key: 333838379
• Report Number: 9610614-2024-00007
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K191234
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2024
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2024
• Date Manufacturer Received: 01/18/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/19/2021
• 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): Hospitalization; Required Intervention
• Patient Age: 41 YR
• Patient Sex: Female