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	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2023
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: laparoscopic appendectomy.Event description: complaint 1 of 2: #(b)(4), (2027111-2023-00711).Complaint 2 of 2: #(b)(4), (current medwatch).Eb210 was inserted through trocar and was found to have a hair-like particle on the device.A second eb210 was opened and was reported to have a layer of dust on the device.The case was completed using the second eb210.No patient injury occurred.Second eb210 is not returning.Additional information received on 30oct2023 via email from account manager: no images of hair taken on the first eb210.No images of the dust taken on the second device.The procedure was completed with the second eb210.Type of intervention: case was completed using the second eb210.Patient status: no patient injury occurred.
Event or Problem Description
Procedure performed: laparoscopic appendectomy.Event description: complaint 1 of 2: #2023-003088 (2027111-2023-00711) complaint 2 of 2: #2023-003089 (current medwatch) eb210 was inserted through trocar and was found to have a hair-like particle on the device.A second eb210 was opened and was reported to have a layer of dust on the device.The case was completed using the second eb210.No patient injury occurred.Second eb210 is not returning.Additional information received on 30oct2023 via email from account manager: no images of hair taken on the first eb210.No images of the dust taken on the second device.The procedure was completed with the second eb210.Type of intervention: case was completed using the second eb210 patient status: no patient injury occurred.
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 would have contributed to the reported event.In the absence of the event unit, it is difficult to determine if the reported event was caused buy 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.

• 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: 18144601
• Report Number: 2027111-2023-00744
• Device Sequence Number: 18018246
• Product Code: GEI
• UDI-Device Identifier: 00607915138424
• UDI-Public: (01)00607915138424(17)260509(30)01(10)1486760
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2024

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: 05/09/2026
• Device Model Number: EB210
• Device Catalogue Number: 101475457
• Device Lot Number: 1486760
• 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: 10/12/2023
• Supplement Date Received by Manufacturer: 10/12/2023
• Initial Report FDA Received Date: 11/15/2023
• Supplement Report FDA Received Date: 03/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/10/2023
• 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
• Patient Sex: Unknown