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

Model Number	EB230
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit has been returned to applied medical for evaluation.A follow-up report will be submitted upon completion of investigation.
Event or Problem Description
Procedure performed: ent procedure.Event description: translation: small problem today with our voyant coagulating device whose screw holding the two branches fell out in the middle of the procedure, requiring the use of a new device.This is the first time this has happened to me with this instrument.Additional information received 04aug22: translation: the two prongs separated above the patient and upon inspection of the device, no screws were missing.In addition, an x-ray of the patient's neck was requested the next day, which did not find a metallic foreign body.The instrument was used for approximately 45 minutes before the problem occurred.This was a total thyroidectomy.Everything went perfectly on the left lobe and the incident occurred during the dissection of the right lobe.Perhaps after about 20 cycles of coagulation.Type of intervention: device replacement.An x-ray of the patient's neck was requested the next day, which did not find a metallic foreign body.Patient status: no concern was mentioned regarding the patient¿s status.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant¿s experience of separated handles.Based on the condition of the returned unit, the reported event was likely caused by an insufficient weld.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.
Event or Problem Description
Procedure performed: ent procedure.Event description: translation: small problem today with our voyant coagulating device whose screw holding the two branches fell out in the middle of the procedure, requiring the use of a new device.This is the first time this has happened to me with this instrument.Additional information received on 04aug22: translation: the two prongs separated above the patient and upon inspection of the device, no screws were missing.In addition, an x-ray of the patient's neck was requested the next day, which did not find a metallic foreign body.The instrument was used for approximately 45 minutes before the problem occurred.This was a total thyroidectomy.Everything went perfectly on the left lobe and the incident occurred during the dissection of the right lobe.Perhaps after about 20 cycles of coagulation.Type of intervention: device replacement.An x-ray of the patient's neck was requested the next day, which did not find a metallic foreign body.Patient status: no concern was mentioned regarding the patient¿s status.

• 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: 17424873
• Report Number: 2027111-2023-00538
• Device Sequence Number: 12655257
• Product Code: GEI
• UDI-Device Identifier: 00607915138240
• UDI-Public: (01)00607915138240(17)240720(30)01(10)1423761
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2023

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: 07/20/2024
• Device Model Number: EB230
• Device Catalogue Number: 101475465
• Device Lot Number: 1423761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2022
• 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: 03/28/2023
• Supplement Date Received by Manufacturer: 03/28/2023
• Initial Report FDA Received Date: 07/31/2023
• Supplement Report FDA Received Date: 07/31/2023
• Date Device Manufactured: 07/21/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown