MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES EB210, VOYANT 5MM FUSION 37CM, 6/BX; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number EB210

Device Problem Device Remains Activated (1525)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/14/2024

Event Type  malfunction  

Event Description

Procedure performed: laparoscopic hysterectomy.Event description: long time voyant users, used device as intended.The device did not stop activating.Even when not holding the activation button.Intervention: device replacement patient status: no clinical impact to the patient.

Manufacturer Narrative

The event unit is anticipated to return to applied medical for evaluation.A follow-up report will be submitted upon completion of investigation.

• Brand Name: EB210, VOYANT 5MM FUSION 37CM, 6/BX
• 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: 18974106
• MDR Text Key: 338574866
• Report Number: 2027111-2024-00465
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00607915138424
• UDI-Public: (01)00607915138424(17)260316(30)01(10)1486218
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EB210
• Device Catalogue Number: 101476432
• Device Lot Number: 1486218
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/15/2024
• Date Device Manufactured: 03/17/2023
• 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; LAPAROSCOPIC INSTRUMENTS