MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES VOYANT OPEN FUSION DEVICE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	EB240
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2024
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 investigation.
Event or Problem Description
Procedure performed: open hysterectomy.Event description: the device was being used normally, activation and cut.The surgeon was using the device normally by complaining from the dissection.At certain point, the knife was broken, and the jaws were not able to open but fortunately outside the patient.The surgeon tried several times to open and closes the handle and the knife but not working.No clinical impact type of intervention: the surgeon continued the case using standard bipolar patient status: no clinical impact.
Event or Problem Description
Procedure performed: open hysterectomy.Event description: the device was being used normally, activation and cut.The surgeon was using the device normally by complaining from the dissection.At certain point, the knife was broken, and the jaws were not able to open but fortunately outside the patient.The surgeon tried several times to open and closes the handle and the knife but not working.No clinical impact type of intervention: the surgeon continued the case using standard bipolar patient status: no clinical impact.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Testing was performed on the event unit, which confirmed complainant¿s experience of jaws staying closed.Based on the condition of the returned unit, it is likely that the reported event was caused by the exposed blade preventing the jaws from fully opening.Applied medical has performed a historical trend analysis and review of production records and no relevant documentation was identified.This event was initially reported based on the description of the event.However, based on the evaluation of the event unit, applied medical determined that this event is not reportable as it is unlikely to cause or contribute to death or serious injury.This determination is based on the fact that the incident happened outside the patient and did not result in any tissue damage.

• Brand Name: VOYANT OPEN FUSION DEVICE
• 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: 20072240
• Report Number: 2027111-2024-00798
• Device Sequence Number: 3034876
• Product Code: GEI
• UDI-Device Identifier: 00607915138455
• UDI-Public: (01)00607915138455
• Combination Product (Y/N): N
• Initial Reporter Country: KU
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2024

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: 10/03/2025
• Device Model Number: EB240
• Device Catalogue Number: 101474398
• Device Lot Number: 1501109
• 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: 08/05/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/26/2024
• Supplement Report FDA Received Date: 11/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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