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

Model Number	EB217
Medical Device Problem Codes	Failure to Deliver Energy (1211); Energy Output Problem (1431)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/12/2023
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: hysterectomy with lymphadectomy, abdominal.Event description: a lymph node resection in lymphadenectomy after hysterectomy was being performed.The device stopped working, it did not seal when activated.There was no clinical impact for the patient.He finished performing the lymphadenectomy with the laparoscopy scissors and the standard bipolar.No other instruments were being used.Information received from applied medical representative via email 28jul23: as explained in the cer, lymph node dissection was being performed.The device had been used for about an hour and a half, the customer does not know the number of activations (approx.# of activations).The activation tone and end tone was heard.There were no thermal effects.Information received from applied medical representative via email 30oct23: the operating room supervisor at the [user facility] notified me on (b)(6) to pick up the defective device, she informed me that the surgery had been on the (b)(6), possibly she was confused when telling me the date and the surgery was performed on previous week, (b)(6).The device is the one that was given to me and the information about the event was confirmed by the supervisor and the gynecologist, when i collected the information.Intervention: he finished performing the lymphadenectomy with the laparoscopy scissors and the standard bipolar.Patient status: favorable.
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.As the event unit was not returned, applied medical is unable to determine if the event unit exhibited any non-conformances that could have contributed to the reported event.In the absence of the event unit, it is difficult to determine if the reported event was caused by a manufacturing non-conformance or circumstantial factors at the time of use.Applied medical has reviewed the details surrounding the event and is unable to determine the exact root cause of the event.
Event or Problem Description
Procedure performed: hysterectomy with lymphoidectomy, abdominal event description: a lymph node resection in lymphadenectomy after hysterectomy was being performed.The device stopped working, it did not seal when activated.There was no clinical impact for the patient.He finished performing the lymphadenectomy with the laparoscopy scissors and the standard bipolar.No other instruments were being used.Information received from applied medical representative via email 28jul23: as explained in the cer, lymph node dissection was being performed.The device had been used for about an hour and a half, the customer does not know the number of activations (approx.# of activations).The activation tone and end tone was heard.There were no thermal effects.Information received from applied medical representative via email 30oct23: the operating room supervisor at the [user facility] notified me on (b)(6) to pick up the defective device, she informed me that the surgery had been on the (b)(6) , possibly she was confused when telling me the date and the surgery was performed on previous week, (b)(6).The device is the one that was given to me and the information about the event was confirmed by the supervisor and the gynecologist, when i collected the information.Intervention: he finished performing the lymphadenectomy with the laparoscopy scissors and the standard bipolar patient status: favorable.

• 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: 18515097
• Report Number: 2027111-2024-00321
• Device Sequence Number: 17830370
• Product Code: GEI
• UDI-Device Identifier: 00607915139377
• UDI-Public: (01)00607915139377(17)250125(30)01(10)1442988
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2024

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: 01/25/2025
• Device Model Number: EB217
• Device Catalogue Number: 101475458
• Device Lot Number: 1442988
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2023
• 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: 07/28/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/15/2024
• Supplement Report FDA Received Date: 07/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/26/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GENERATOR.
• Patient Sex: Unknown