MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES EB213, VOYANT MARYLAND SINGLE 44CM, 6/BX; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number EB213

Device Problem Self-Activation or Keying (1557)

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

Event Date 12/08/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Procedure performed: laparoscopic modified duodenal switch.Event description: dr.[(b)(6)] performed a modified duodenal switch using the voyant maryland single step.The seal activation button got stuck and a new device had to be opened.It was noted that an error message was present on the generator as well, but the specific error was not notated.No adverse effect occurred.Applied rep was not present for case.Product is available for return.Type of intervention: a new device had to be opened.Patient status: no adverse effect occurred.

• Brand Name: EB213, VOYANT MARYLAND SINGLE 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: 18331995
• MDR Text Key: 330959413
• Report Number: 2027111-2023-00856
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00607915140809
• UDI-Public: (01)00607915140809(17)260710(30)01(10)1496435
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K222284
• 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: 12/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EB213
• Device Catalogue Number: 101474691
• Device Lot Number: 1496435
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/08/2023
• Date Device Manufactured: 07/11/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: VOYANT GENERATOR.