MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES EB211, VOYANT 5MM FUSION 44CM, 6/BX; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	EB211
Medical Device Problem Code	Self-Activation or Keying (1557)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: bypass event description: translation: once connected, messages appeared repeatedly.Impossible to use the dm.After plugging in the device, messages appeared from the first use (clean device).Impossibility of use.Repeated messages additional information received from applied medical representative via email (b)(6)2022: translation: there were no consequences, injury or otherwise, for the patient but a bad coagulation that generated several catches and increased the stress of the surgery.No consequences to report for the patient.Additional information received from applied medical representative via email (b)(6)2023: this statement means no consequence for the patient and the surgery took longer than expected due to this problem with the voyant device.The device activated but the coagulation was bad and several messages appeared repeatedly on the generator such as ¿clean the device ¿ type of intervention: device replacement patient status: there were no consequences, injury or otherwise.The surgery took longer than expected due to this problem with the voyant device.
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 was returned to applied medical for evaluation.Testing was performed on the event unit, which confirmed the complainant¿s experience of device alarms.Engineering also observed unintended rf activation during functional testing.Based on the description of the event unit and the condition of the returned unit, it is likely that the reported event was caused by a misaligned fuse switch.Based on the initial description of the event, the event was not reportable as device alarms are unlikely to cause or contribute to death or serious injury.However, based on the evaluation of the returned unit, applied medical determined that this event is reportable due to the event unit experiencing unintended rf activation.Correction to section g3: update to correct receipt date.
Event or Problem Description
Procedure performed: bypass event description: translation: once connected, messages appeared repeatedly.Impossible to use the dm.After plugging in the device, messages appeared from the first use (clean device).Impossibility of use.Repeated messages.Additional information received from applied medical representative via email 01dec22: translation: there were no consequences, injury or otherwise, for the patient but a bad coagulation that generated several catches and increased the stress of the surgery.No consequences to report for the patient.Additional information received from applied medical representative via email 6dec23: this statement means no consequence for the patient and the surgery took longer than expected due to this problem with the voyant device.The device activated but the coagulation was bad and several messages appeared repeatedly on the generator such as ¿clean the device.¿ type of intervention: device replacement.Patient status: there were no consequences, injury or otherwise.The surgery took longer than expected due to this problem with the voyant device.

• Brand Name: EB211, VOYANT 5MM FUSION 44CM, 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: 17344422
• Report Number: 2027111-2023-00524
• Device Sequence Number: 20468957
• Product Code: GEI
• UDI-Device Identifier: 00607915138431
• UDI-Public: (01)00607915138431(17)240722(30)01(10)1424625
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2023

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: 07/22/2024
• Device Model Number: EB211
• Device Catalogue Number: 101475462
• Device Lot Number: 1424625
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/24/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2022
• Supplement Date Received by Manufacturer: 01/04/2023
• Initial Report FDA Received Date: 07/18/2023
• Supplement Report FDA Received Date: 08/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/23/2021
• 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: GENERATOR.
• Patient Sex: Unknown