MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES EB240, VOYANT OPEN FUSION, 6 B/X; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number EB240

Device Problem Difficult to Open or Close (2921)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 09/20/2023

Event Type  Injury  

Manufacturer Narrative

The event unit is not returning to applied medical for evaluation.A follow-up report will be submitted upon completion of investigation.

Event Description

Procedure performed: prostato-cystectomie bricker.Event description: when the surgeon activate the blade during the fusion cycle.The voyant stop the fusion cycle and stay blocked with the jaw closed.The tissues was very tough (says the surgeons).When they dissect the posterieur of the prostate, on the "ailerons", the surgeon activate the energie and before the end of the cycle he activate the blade.In the same time, he had the hand handle (cliped so ready to be open).The fusion cycle stopped and the jaw of the voyant were stucked closed with the blade inside.He tried to re open it later by pushing the handle strongly and tried to activate the blade in the same time.And the jaws finally re opened.But he decide to not use it anymore (for this day) additional information received from the field team member via email on 27sept23: there was no tissue damage when removing the device.There was tissue bleeding.This is the second time this event occurs in in this hospital, the first time we didn¿t make a cer.The surgeons succeeded to unblock it the first time).The device was in use for 1 hour before the event was observed.Additional information received from field team member via email on 29sept23: the issue was observed twice in the same procedure.They were able to open the jaws.Additional information received from field team member via teams call on 29sept23: the doctor did not perceive this as an issue and no patient harm occurred as a result of this event.Additional information received from field team member via email on 02oct23: the blade was deployed while they tried to open the jaws.Intervention: opened the jaws by pushing the handle strongly.Patient status: no clinical impact to the patient.

• Brand Name: EB240, VOYANT OPEN FUSION, 6 B/X
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: farah azmi ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497138710
• MDR Report Key: 18897927
• MDR Text Key: 337593728
• Report Number: 2027111-2024-00436
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K201212
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 03/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: EB240
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/13/2024
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: GENERATOR, BI POLAR; THREAD-REUSABLE MAT.
• Patient Outcome(s): Other