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

Model Number EB215

Device Problem Mechanical Jam (2983)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 06/20/2023

Event Type  malfunction  

Manufacturer Narrative

The event device has returned to applied medical for evaluation.A follow-up report will be provided upon completion of investigation.

Event Description

Procedure performed: lap.Sigma.Event description: complaint 1 of 2: (b)(4).Complaint 2 of 2: (b)(4).After 45 minutes in the procedure the surgeon was unable to open the jaws.Only with a lot of force.He decided to open an new eb215 to be on the safe side.After another 30 minutes the same occurs and he decided to use the [brand name redacted].His suggestion was that the device would stick too quickly.And in his eyes it is to dangerous to work under this circumstances information received by applied medical rep via email on 3jul23: the handle was getting stuck in the latched position preventing the jaws from opening.There was tissue damage and tissue bleeding when the device was being removed.This problem was observed 3 to 5 times.The device was being used for 30 minutes.Additional information received by applied medical rep via email on 23oct23: i have not more information as i had sent you in attached email.Intervention: device replacement patient status: nothing.

• 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: 18976011
• MDR Text Key: 339131475
• Report Number: 2027111-2024-00468
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00607915139353
• UDI-Public: (01)00607915139353(17)260113(30)01(10)1478251
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: Other
• 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: EB215
• Device Catalogue Number: 101476434
• Device Lot Number: 1478251
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2023
• Was the Report Sent to FDA?: No
• Date Device Manufactured: 01/14/2023
• 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