MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES VOYANT MARYLAND FUSION DEVICE WITH SINGLE-STEP ACTIVATION; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	EB212
Medical Device Problem Codes	Break (1069); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event device has returned to applied medical for evaluation.A follow-up report will be provided upon completion of investigation.
Event or Problem Description
Procedure performed: [robot-assisted gastrectomy] event description: hospital: [hospital name] report from the sales rep via email; the knife of the handpiece had popped out when the package was opened.The person in charge of opening the package was almost injured.This unit will be returned.The investigation report has been requested by the hospital.Amj always sells medical devices to sales dealers, then the dealer sells them to hospitals.Per amj operation team, the device was purchased through a sales dealer.The lot trace was performed using account id (b)(4).Type of intervention: [replaced to a hospital inventory new product and the procedure was completed.] patient status: [no patient injury or illness associated with this event.].
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Testing was performed on the event unit, which confirmed that had the upper jaw conductive pad exposed and sticking out of the jaws.The blade was intact within the jaws.Applied medical has reviewed the details surrounding the event and related products and is unable to determine the cause of the reported event based on the evaluation of the returned unit.Applied medical has performed a historical trend analysis and review of production records and no relevant documentation was identified.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.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: [robot-assisted gastrectomy].Event description: hospital: [hospital name] report from the sales rep via email.The knife of the handpiece had popped out when the package was opened.The person in charge of opening the package was almost injured.This unit will be returned.The investigation report has been requested by the hospital.(b)(6) always sells medical devices to sales dealers, then the dealer sells them to hospitals.Per (b)(6) operation team, the device was purchased through a sales dealer.The lot trace was performed using account id (b)(6).***additional information entered on 12dec2024*** the fi team again confirmed with the hospital that there was a device log.The fi team checked again with the hospital to see if there was a device log.The fi team found that the device was ¿before use because it was discovered when the package was opened and had not been placed in the patient's body cavity.On the other hand, the reason why there was a device log could not be determined.Type of intervention: [replaced to a hospital inventory new product and the procedure was completed.] patient status: [no patient injury or illness associated with this event.].

• Brand Name: VOYANT MARYLAND FUSION DEVICE WITH SINGLE-STEP ACTIVATION
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: ashleigh mendez ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497135359
• MDR Report Key: 20870118
• Report Number: 2027111-2024-00944
• Device Sequence Number: 15596960
• Product Code: GEI
• UDI-Device Identifier: 00607915140793
• UDI-Public: (01)00607915140793
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2025

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: 07/02/2026
• Device Model Number: EB212
• Device Catalogue Number: 101474715
• Device Lot Number: 1497306
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/06/2024
• Supplement Report FDA Received Date: 08/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/03/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Patient Sex: Unknown