MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES EB230, VOYANT FINE FUSION, 6/BX; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	EB230
Medical Device Problem Code	Energy Output Problem (1431)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit is anticipated to return to applied medical for evaluation.A follow-up report will be submitted upon completion of the investigation.
Event or Problem Description
Procedure performed: hysterectomy.Event description: complaint 1 of 2: (b)(4).Complaint 2 of 2: (b)(4).Issue with 2 x fine fusion during the same surgical procedure.Devices used as usual by the same surgeon.The third fine fusion devices replacing the 2 defect ones worked normally.When the doctor wanted to cauterize, nothing happened.No heat, no cauterization and apparently no error signal on the generator.Devices replaced by a third one during the same intervention.And surgeon was able to perform his surgery.Additional information received by applied medical rep via email on 9nov23: date of event: 20.09.23.Hemorrhoids were being grasped when the incident occurred.The problem occurred in the first minute.They heard the activation and end tone, but coagulation was not occurring, so we had to change the indicator.No thermal effects visible at the site.Type of intervention: device replacement.Patient status: no clinical impact to the patient.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Testing was performed on the event unit; however, the complainant¿s experience could not be replicated or confirmed as the event unit met current specifications.Applied medical was reviewed the details surrounding the event and related products and is unable to determine the cause of the reported event or confirm that a product malfunction occurred.
Event or Problem Description
Procedure performed: hysterectomy.Event description: complaint 1 of 2: (b)(4).Complaint 2 of 2: (b)(4).Issue with 2 x fine fusion during the same surgical procedure.Devices used as usual by the same surgeon.The third fine fusion devices replacing the 2 defect ones worked normally.When the doctor wanted to cauterize, nothing happened.No heat, no cauterization and apparently no error signal on the generator.Devices replaced by a third one during the same intervention.And surgeon was able to perform his surgery.Additional information received by applied medical rep via email on 9nov23: date of event: 20.09.23.Hemorrhoids were being grasped when the incident occurred.The problem occurred in the first minute.They heard the activation and end tone, but coagulation was not occurring, so we had to change the indicator.No thermal effects visible at the site.Type of intervention: device replacement.Patient status: no clinical impact to the patient.

• Brand Name: EB230, VOYANT FINE FUSION, 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: 18178899
• Report Number: 2027111-2023-00767
• Device Sequence Number: 7611819
• Product Code: GEI
• UDI-Device Identifier: 00607915138240
• UDI-Public: (01)00607915138240(17)260117(30)01(10)1479802
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K202818
• 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): 05/30/2024

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: 01/17/2026
• Device Model Number: EB230
• Device Catalogue Number: 101476431
• Device Lot Number: 1479802
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 11/09/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/20/2023
• Supplement Report FDA Received Date: 05/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/18/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GENERATOR
• Patient Sex: Unknown