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	Self-Activation or Keying (1557)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: ovariectomy/tubectomy/adnexectomy.Event description: info received from applied medical representative via email 8may23: the eb210 refused working from the start of the procedure.No sound, no sealing activity.Event occurred on april 12th.Name of procedure being performed was ovariectomy/tubectomy/adnexectomy.The event happened during use, at the beginning of the procedure.There was no patient injury, patient status is okay.The user restarted the generator, plugged out the eb210 and reconnected, took a new device.Update to reportability via device evaluation on 19may2023: a misaligned fuse switch was found during evaluation, leading to unintended rf activation.Type of intervention: restarted the generator, plugged out the eb210 and reconnected.Took a new device.Patient status: okay.
Additional Manufacturer Narrative
The event unit has returned to applied medical for evaluation.A follow-up report will be submitted upon completion of investigation.
Event or Problem Description
Procedure performed: ovariectomy/tubectomy/adnexectomy event description: info received from applied medical representative via email 8may23: the eb210 refused working from the start of the procedure.No sound, no sealing activity.Event occurred on april 12th.Name of procedure being performed was ovariectomy/tubectomy/adnexectomy.The event happened during use, at the beginning of the procedure.There was no patient injury, patient status is okay.The user restarted the generator, plugged out the eb210 and reconnected, ¿ took a new device.Update to reportability via device evaluation on 19may2023: a misaligned fuse switch was found during evaluation, leading to unintended rf activation type of intervention: restarted the generator, plugged out the eb210 and reconnected.Took a new device.Patient status: okay.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Functional testing confirmed the complainant¿s experience of no sealing activity.Engineering also observed unintended rf energy output without activation of the device.Upon closer inspection, the fuse switch, an internal component of the unit, was observed to be misaligned.Based on the condition of the returned unit and the description of the event, it is likely that the reported event was caused by the misaligned fuse switch.Based upon the initial description of the event, the event was not reportable as it is 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 as unintended rf energy output is likely to cause or contribute to death or serious injury.

• 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: 17109679
• Report Number: 2027111-2023-00485
• Device Sequence Number: 15021138
• Product Code: GEI
• UDI-Device Identifier: 00607915138424
• UDI-Public: (01)00607915138424(17)250328(30)01(10)1449476
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2023

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: 03/28/2025
• Device Model Number: EB210
• Device Catalogue Number: 101475457
• Device Lot Number: 1449476
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2023
• Supplement Date Received by Manufacturer: 05/19/2023
• Initial Report FDA Received Date: 06/12/2023
• Supplement Report FDA Received Date: 08/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/29/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GENERATOR
• Patient Sex: Unknown