MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES EB210, VOYANT 5MM FUSION 37CM, 6/BX; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	EB210
Medical Device Problem Code	Energy Output Problem (1431)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: low anterior resection.Event description: hospital: [name] product: eb210 this instrument tested fine before surgery, but during its use, it intermittently exhibits functionality issues, working properly at times and malfunctioning at others.Furthermore, ea020 did not detect any abnormalities with eb210.Product available for return.Additional information received on 03may2024: when the eb210 is activated, it sometimes works like an electrocautery, but sometimes it does not.In the attached video, ea020 recognizes that eb210 has been activated, but the surgeons collectively shouted "no" (indicating a lack of activation), confirming the unstable activation of the function.According to user feedback, the tissue is not thick, and although the device can seal the tissue, occasionally the seal does not work.Type of intervention: user replaces with a new eb210 to complete the surgery.Patient status: there is no impact to patient.
Additional Manufacturer Narrative
The event unit has returned to applied medical for evaluation.A follow-up report will be submitted upon completion of investigation.
Additional Manufacturer Narrative
The event unit returned to applied medical for evaluation.Testing was performed on the event unit.However, the complainant¿s experience of apparent low rf output could not be confirmed as an open circuit was discovered in the jaw weld.Functional testing to confirm the sealing capabilities of the unit was unable to be performed.Applied medical has performed a historical trend analysis and review of production records and no relevant documentation was identified.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.
Event or Problem Description
Procedure performed: low anterior resection.Event description: hospital: [name].Product: eb210.This instrument tested fine before surgery, but during its use, it intermittently exhibits functionality issues, working properly at times and malfunctioning at others.Furthermore, ea020 did not detect any abnormalities with eb210.Product available for return.Additional information received on 03may2024: when the eb210 is activated, it sometimes works like an electrocautery, but sometimes it does not.In the attached video, ea020 recognizes that eb210 has been activated, but the surgeons collectively shouted "no" (indicating a lack of activation), confirming the unstable activation of the function.According to user feedback, the tissue is not thick, and although the device can seal the tissue, occasionally the seal does not work.Type of intervention: user replaces with a new eb210 to complete the surgery.Patient status: there is no impact to patient.

• Brand Name: EB210, VOYANT 5MM FUSION 37CM, 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: 19725755
• Report Number: 2027111-2024-00746
• Device Sequence Number: 8275319
• Product Code: GEI
• UDI-Device Identifier: 00607915138424
• UDI-Public: (01)00607915138424(17)251017(30)01(10)1470747
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2024

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: 10/17/2025
• Device Model Number: EB210
• Device Catalogue Number: 101475457
• Device Lot Number: 1470747
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/03/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/11/2024
• Supplement Report FDA Received Date: 08/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/18/2022
• 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
• Patient Sex: Unknown