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

Model Number	EB240
Medical Device Problem Codes	Self-Activation or Keying (1557); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Procedure performed: sigmoidectomy.Event description: the surgeon received a "check stuck button" error when the device was initially plugged in.The alarm was cleared, and the surgeon proceeded with the case.The device was working fine for 16 activations.On the 17th activation, the jaws would not open when they were sealing on the mesentery of the rectal wall.The device would not unlatch again when the surgeon was sealing a small bundle on the 18th activation.The device made noises that indicated that the device was unlatching but the jaws were unresponsive to the handle mechanism.No audible noise or visual damage to the device was observed prior to the experience.It is unknown if the blade lever was not returning to the forward position when released.No bleeding occurred.The surgeon stitched around the device and cut the device to the remove it from the patient.No patient injury occurred as a result of the event.Type of intervention: the surgeon stitched around the device and cut the device to remove it from the patient.Patient status: no patient injury occurred as a result of the event.
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: sigmoidectomy.Event description: the surgeon received a "check stuck button" error when the device was initially plugged in.The alarm was cleared, and the surgeon proceeded with the case.The device was working fine for 16 activations.On the 17th activation, the jaws would not open when they were sealing on the mesentery of the rectal wall.The device would not unlatch again when the surgeon was sealing a small bundle on the 18th activation.The device made noises that indicated that the device was unlatching but the jaws were unresponsive to the handle mechanism.No audible noise or visual damage to the device was observed prior to the experience.It is unknown if the blade lever was not returning to the forward position when released.No bleeding occurred.The surgeon stitched around the device and cut the device to the remove it from the patient.No patient injury occurred as a result of the event.Type of intervention: the surgeon stitched around the device and cut the device to remove it from the patient.Patient status: no patient injury occurred as a result of the event.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Functional testing confirmed the complainant¿s experience of the jaws not opening.Upon closer inspection, the pawl spring, an internal component used to latch and unlatch the handle, did not meet specifications.Additional testing could not confirm the customer¿s experience of unintended rf output as the event unit passed functional testing.Based on the condition of the returned unit, the reported event of jaws not opening was due to a nonconforming pawl spring.Additionally, applied medical has reviewed the details surrounding the event of unintended rf output and is unable to determine the cause of the reported event based on the evaluation of the returned unit.The probability and criticality of harm resulting from these failures have been evaluated and were found to be at an acceptable level.

• 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: aaron fulcher ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497135765
• MDR Report Key: 16649877
• Report Number: 2027111-2023-00405
• Device Sequence Number: 5340427
• Product Code: GEI
• UDI-Device Identifier: 00607915138455
• UDI-Public: (01)00607915138455(17)241110(30)01(10)1467050
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 06/23/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/10/2024
• Device Model Number: EB240
• Device Catalogue Number: 101474615
• Device Lot Number: 1467050
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2023
• Supplement Date Received by Manufacturer: 03/14/2023
• Initial Report FDA Received Date: 03/30/2023
• Supplement Report FDA Received Date: 06/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/22/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: MONOPOLAR CAUTERY, STAPLER.
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown