MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES EB216, VOYANT MARYLAND FUSION 44CM, 6/BX; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number EB216

Device Problem Self-Activation or Keying (1557)

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

Event Date 02/12/2024

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: laparoscopic gastric sleeve.Event description: hospital: [institution].Product: eb216."during the case, the first activation of the device was successful.However, for the subsequent activation, the activation button got stuck, and the generator showed ¿check for stuck button¿ alarm.The surgeon checked the button and tried another activation.The activation button was stuck again with the tissues in between the jaws.The product unlatched fine, but the problem regarding stuck activation button continued.The surgeon opened a new voyant handpiece to complete the surgery.There was no patient injury.Product available for return.Intervention: the case was completed with the new one.Patient status: no patient injury.

• Brand Name: EB216, VOYANT MARYLAND FUSION 44CM, 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: 18792991
• MDR Text Key: 336862699
• Report Number: 2027111-2024-00421
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200598
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EB216
• Device Catalogue Number: 101475464
• Device Lot Number: 1477993
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2024
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/12/2024
• Date Device Manufactured: 01/17/2023
• 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: TROCAR