MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES EB240, VOYANT OPEN FUSION, 6 B/X; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	EB240
Medical Device Problem Code	Energy Output Problem (1431)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/02/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit will not be returning to applied medical for evaluation.A follow-up report will be submitted upon completion of investigation.
Event or Problem Description
Procedure performed: low anterior resection (lar).Event description: the rep was present for the case, and it was an open case used with an alexis.On the very first activation the device did not seal.The jaws clamped both sides with ima in between.The generator beeped a number of times during the seal cycle and the end tones were heard but it took longer than usual to complete the seal cycle.The device did not seal at all.The vessel was cut and tied with sutures.The device was not used for some time as the surgeon was teaching how to cut & tie with sutures.Later in the case, the device was used again and for the second and third activations it worked fine.They completed the case with the same device.There was no adverse patient injury.The product will not return.Additional information was received via email on 10nov2022 from [voyant project manager, applied medical]: "no alarms sounded".The blade was activated after hearing the end tone.Yes, bleeding was experienced after activating the blade.The patient did not exhibit any vascular pathology, nor was the device activated on diseased or inflamed tissue.Zero tissue effects were observed at the seal site.Type of intervention: cut & tied with sutures.Patient status: no adverse patient injury.
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: low anterior resection (lar).Event description: the rep was present for the case, and it was an open case used with an alexis.On the very first activation the device did not seal.The jaws clamped both sides with ima in between.The generator beeped a number of times during the seal cycle and the end tones were heard but it took longer than usual to complete the seal cycle.The device did not seal at all.The vessel was cut and tied with sutures.The device was not used for some time as the surgeon was teaching how to cut & tie with sutures.Later in the case, the device was used again and for the second and third activations it worked fine.They completed the case with the same device.There was no adverse patient injury.The product will not return.Additional information was received via email on 10nov2022 from [voyant project manager, applied medical]: "no alarms sounded".The blade was activated after hearing the end tone.Yes, bleeding was experienced after activating the blade.The patient did not exhibit any vascular pathology, nor was the device activated on diseased or inflamed tissue.Zero tissue effects were observed at the seal site.Type of intervention: cut & tied with sutures.Patient status: no adverse patient injury.

• Brand Name: EB240, VOYANT OPEN FUSION, 6 B/X
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: aaron fulcher ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497135765
• MDR Report Key: 15830541
• Report Number: 2027111-2022-00828
• Device Sequence Number: 17371845
• Product Code: GEI
• UDI-Device Identifier: 00607915138455
• UDI-Public: (01)00607915138455(17)241004(30)01(10)1463008
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K201212
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2023

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: 10/04/2024
• Device Model Number: EB240
• Device Catalogue Number: 101474615
• Device Lot Number: 1463008
• Was Device Available for Evaluation?: No
• 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: 11/02/2022
• Supplement Date Received by Manufacturer: 11/02/2022
• Initial Report FDA Received Date: 11/19/2022
• Supplement Report FDA Received Date: 01/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/16/2022
• 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: ALEXIS
• Patient Sex: Unknown