MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES EB215, VOYANT MARYLAND FUSION 37CM, 6/BX; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number EB215

Device Problem Self-Activation or Keying (1557)

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

Event Date 02/22/2024

Event Type  malfunction  

Manufacturer Narrative

The event unit is anticipated to return to applied medical.A follow up report will be provided following the completion of the investigation.

Event Description

Type of procedure: unknown event description: the trigger activates by itself or does not work.Operating lock.Patient status: no clinical impact to the patient has been reported intervention: used new handpiece.

• Brand Name: EB215, VOYANT MARYLAND 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: 19183557
• MDR Text Key: 341121948
• Report Number: 2027111-2024-00606
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00607915139353
• UDI-Public: (01)00607915139353(17)260731(30)01(10)1500737
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K200598
• 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: 04/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EB215
• Device Catalogue Number: 101476434
• Device Lot Number: 1500737
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/28/2024
• Date Device Manufactured: 08/01/2023
• 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