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	Self-Activation or Keying (1557)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit will not be returning to applied medical.A follow-up report will be submitted upon completion of investigation.
Event or Problem Description
Procedure performed: whipple.Event description: "surgeon feedback for transection trigger is a bit hard.Easy to unintentionally press the activate button during manipulation." additional information was received via email on 19sep2023 from territory manager" the surgeon said the blade lever required more force to activate comparing to [competitor device].So, he just applied more force.This issue was observed within the first case.The device was activated around 3 times before the experience occurred.Additional information was received via email on 25sep2023 from territory manager: the date the feedback was originally collected was on the date of the event, (b)(6) 2023, not (b)(6) 2023.Product not available for return.Type of intervention: "yes".Patient status: normal.
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: whipple.Event description: "surgeon feedback for transection trigger is a bit hard.Easy to unintentionally press the activate button during manipulation." additional information was received via email on 19sep2023 from territory manager" the surgeon said the blade lever required more force to activate comparing to [competitor device].So, he just applied more force.This issue was observed within the first case.The device was activated around 3 times before the experience occurred.Additional information was received via email on 25sep2023 from territory manager: the date the feedback was originally collected was on the date of the event, 29aug2023, not 30may2023.Product not available for return type of intervention: "yes".Patient status: normal.

• 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: farah azmi ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497138710
• MDR Report Key: 17865768
• Report Number: 2027111-2023-00617
• Device Sequence Number: 12184094
• Product Code: GEI
• UDI-Device Identifier: 00607915138455
• UDI-Public: (01)00607915138455(17)250703(30)01(10)1488015
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2024

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: 07/03/2025
• Device Model Number: EB240
• Device Catalogue Number: 101474615
• Device Lot Number: 1488015
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/03/2023
• Supplement Report FDA Received Date: 05/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/15/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: MONOPOLAR CAUTERY
• Patient Sex: Unknown