MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES EB240, VOYANT OPEN FUSION, 6 B/X; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	EB240
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	06/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: total abdominal hysterectomy with bilateral salpingo-oophorectomy event description: we had a defective device this morning in surgery.Product is available for return.Additional information received on 28jun2023 via email from assistant director of surgery: there was no patient injury from the defective device.The surgery was completed by opening an additional voyant open fusion.In terms of malfunction, this device would clamp down and would not burn.Was also sticking and difficult to unclamp.Additional information received on 29jun2023 via email from assistant director of surgery: the device malfunctioned while grasping fallopian tube on the first activation.The activation and end tones were heard, with thermal effects visible at the seal site.Some minor bleeding and oozing was caused when trying to open the jaws, since the device had to be removed while still clamped down.Tension was applied to the vessel and bundle being sealed.No eschar built up on the jaws.There were no generator alarms that interrupted the seal cycle.The device was not activated on diseased or inflamed tissue.Type of intervention: the surgery was completed by opening an additional voyant open fusion.Patient status: there was no patient injury from the defective 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 returned unit, which confirmed the complainant¿s experience of the jaws not opening.Engineering observed that the pawl spring, an internal component of the handle, had a gap that was outside of specification.Based on the conditions of the returned unit, the reported event was likely caused by the gap between the two legs of the pawl spring, which prevented the jaws from opening.
Event or Problem Description
Procedure performed: total abdominal hysterectomy with bilateral salpingo-oophorectomy.Event description: we had a defective device this morning in surgery.Product is available for return.Additional information received on 28jun2023 via email from assistant director of surgery: there was no patient injury from the defective device.The surgery was completed by opening an additional voyant open fusion.In terms of malfunction, this device would clamp down and would not burn.Was also sticking and difficult to unclamp.Additional information received on 29jun2023 via email from assistant director of surgery: the device malfunctioned while grasping fallopian tube on the first activation.The activation and end tones were heard, with thermal effects visible at the seal site.Some minor bleeding and oozing was caused when trying to open the jaws, since the device had to be removed while still clamped down.Tension was applied to the vessel and bundle being sealed.No eschar built up on the jaws.There were no generator alarms that interrupted the seal cycle.The device was not activated on diseased or inflamed tissue.Type of intervention: the surgery was completed by opening an additional voyant open fusion.Patient status: there was no patient injury from the defective device.

• Brand Name: EB240, VOYANT OPEN FUSION, 6 B/X
• 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: 18841927
• Report Number: 2027111-2024-00427
• Device Sequence Number: 15317836
• Product Code: GEI
• UDI-Device Identifier: 00607915138455
• UDI-Public: (01)00607915138455(17)250110(30)01(10)1473007
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/10/2025
• Device Model Number: EB240
• Device Catalogue Number: 101474615
• Device Lot Number: 1473007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/05/2024
• Supplement Report FDA Received Date: 04/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/22/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown