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	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Name of procedure being performed: laparoscopic appendectomy.Detailed description of event: (b)(6).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.First eb210 is available for return.Additional information received on 30oct2023 via email from [name], 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.Patient status: no patient injury occurred.Type of intervention: the case was completed using the second eb210.
Additional Manufacturer Narrative
The event device is anticipated to return.A follow-up report will be provided upon completion of the investigation.
Event or Problem Description
Name of procedure being performed: laparoscopic appendectomy detailed description of event: [hospital].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.First eb210 is available for return.Additional information received on 30oct2023 via email from [name], 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.Patient status: no patient injury occurred.Type of intervention: the case was completed using the second eb210.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection was performed on the event unit.However, the complainant¿s experience could not be replicated or confirmed as the presence of hair on the device was not observed.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.The probability and criticality of harm resulting from this event have been evaluated and were found to be at an acceptable level.

• 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: 18097324
• Report Number: 2027111-2023-00711
• Device Sequence Number: 12449549
• 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): 03/21/2024

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?: Device Returned to Manufacturer
• 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: 11/08/2023
• Supplement Report FDA Received Date: 03/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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