MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES EB217, VOYANT MARYLAND FUSION 23CM, 6/BX; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	EB217
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Procedure performed: subtotal gastrectomy.Event description: they were sealing and cutting the tissues.During the operation, after the tissues were sealed and the cut was made, the blade became stuck on the trigger.This was observed more than once.Due to this situation, the jaws could not be opened after opening the probe handle lock.Another product was used to open the jaws.It caused tissue damage and bleeding.The case was continued with another voyant probe.Additional information received on 27 february 2024 by [distributor] by email: they have standard bipolar, monopolar and open instruments.They stop bleeding standard bipolar then second voyant probe.Yes , they cut the tissue with scissors.Operation successfully completed.Patient condition is good.They hardly pull the blade layer button(scrup nurse), then the locking mechanism is free then jaws opened.Intervention: another product was used to open the jaws.The case was continued with another voyant probe.Patient status: only little bleeding.Operation successfully completed.Patient condition is good.
Additional Manufacturer Narrative
The event device is anticipated to be returned to applied medical for evaluation.A follow-up report will be provided upon completion of investigation.
Additional Manufacturer Narrative
The event unit returned to applied medical for evaluation.Testing was performed on the event unit, which confirmed the complainant¿s experience of the jaws remaining closed.Engineering observed the blade to be bent within the pull tube.Based on the condition of the returned unit, it is likely that the reported event was caused by the bent blade.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.
Event or Problem Description
Procedure performed: subtotal gastrectomy.Event description: they were sealing and cutting the tissues.During the operation, after the tissues were sealed and the cut was made, the blade became stuck on the trigger.This was observed more than once.Due to this situation, the jaws could not be opened after opening the probe handle lock.Another product was used to open the jaws.It caused tissue damage and bleeding.The case was continued with another voyant probe.Additional information received on 27 february 2024 by [name] by email: when the event complaint occurred, they doctors were using as well a standard bipolar, monopolar and open instruments.The bleeding in the patient was caused by eb217 device.To stop the bleeding, the doctors used a standard bipolar device then a second voyant probe.As the jaws were not opening, to be able to open them, the doctors had to cut the tissue with scissors and then to be able to release the jaws, the doctors and scrub nurse after having hard times to pull the blade layer button, they could have the locking mechanism free and then the jaws were opened.When the case continued with another voyant probe, the operation was successfully completed and the patient was in good conditions.Intervention: another product was used to open the jaws.The case was continued with another voyant probe.Patient status: only little bleeding.Operation successfully completed.Patient condition is good.

• Brand Name: EB217, VOYANT MARYLAND FUSION 23CM, 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: 18842194
• Report Number: 2027111-2024-00428
• Device Sequence Number: 18006740
• Product Code: GEI
• UDI-Device Identifier: 00607915139377
• UDI-Public: (01)00607915139377(17)260507(30)01(10)1491607
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K200598
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/07/2026
• Device Model Number: EB217
• Device Catalogue Number: 101476436
• Device Lot Number: 1491607
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/05/2024
• Supplement Report FDA Received Date: 06/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/08/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown