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

Model Number	EB213
Medical Device Problem Codes	Device Alarm System (1012); Self-Activation or Keying (1557)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2023
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Testing was performed on the event unit, which confirmed the customer¿s experience of device alarms.Based on the condition of the returned unit, it is likely that the reported event was caused by a compromised resistance weld within the jaws of the device.This event was initially reported based on the description of the event.However, based on the evaluation of the returned unit, applied medical determined that this event is not reportable as it is unlikely to cause or contribute to death or serious injury.
Event or Problem Description
Procedure performed: laparoscopic modified duodenal switch.Event description: dr.[name] 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.Additional information received via email on 19jan2024: the facility may have meant the blade lever was sticking, but i'm not sure.The only information i was given on that device was that the button was stuck.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
• Common Device Name: 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
• Report Number: 2027111-2023-00856
• Device Sequence Number: 6938069
• Product Code: GEI
• UDI-Device Identifier: 00607915140809
• UDI-Public: (01)00607915140809(17)260710(30)01(10)1496435
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K222284
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/10/2026
• Device Model Number: EB213
• Device Catalogue Number: 101474691
• Device Lot Number: 1496435
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/14/2023
• Supplement Report FDA Received Date: 08/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/11/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: VOYANT GENERATOR.
• Patient Sex: Unknown