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

Model Number EB240

Device Problem Self-Activation or Keying (1557)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/09/2023

Event Type  malfunction  

Manufacturer Narrative

The event unit will not be returning to applied medical for evaluation.A follow-up report will be submitted upon completion of investigation.

Event Description

Type of procedure: unk.Event description: the surgeon noted that he would reach for the blade lever and accidentally activate the energy button when he transected the tissue after the completed seal.The rep noticed this during his case the week prior as well.Product is not available for return.Additional information was received via email on 17nov2023 from applied medical project manager no patient injury occurred.It is unknown how many instances the surgeon accidentally activated the energy button when using the voyant device.This was observed a handful of times.It is unknown how long the device been used before the experience was observed.No generator alarms interrupted the seal cycle.The jaws of the device were cleaned during the procedure.The surgeon was not able to find a resolution.Patient status: no patient injury occurred.Fine and well.Intervention: the surgeon was not able to find a resolution.

Manufacturer Narrative

The event unit was not returned to applied medical for evaluation.As the event unit was not returned, applied medical is unable to determine if the event unit exhibited any non-conformances that could have contributed to the reported event.In the absence of the event unit, it is difficult to determine if the reported event was caused by a manufacturing non-conformance or circumstantial factors at the time of use.Applied medical has reviewed the details surrounding the event and is unable to determine the exact root cause of the event.

Event Description

Type of procedure: unk.Event description: the surgeon noted that he would reach for the blade lever and accidentally activate the energy button when he transected the tissue after the completed seal.The rep noticed this during his case the week prior as well.Product is not available for return.Additional information was received via email on 17nov2023 from applied medical project manager no patient injury occurred.It is unknown how many instances the surgeon accidentally activated the energy button when using the voyant device.This was observed a handful of times.It is unknown how long the device been used before the experience was observed.No generator alarms interrupted the seal cycle.The jaws of the device were cleaned during the procedure.The surgeon was not able to find a resolution.Patient status: no patient injury occurred.Fine and well.Intervention: the surgeon was not able to find a resolution.

• Brand Name: EB240, VOYANT OPEN FUSION, 6 B/X
• Type of Device: 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: 18331573
• MDR Text Key: 330966078
• Report Number: 2027111-2023-00855
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201212
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/20/2024

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
• Device Operator: Health Professional
• Device Model Number: EB240
• Device Catalogue Number: 101474615
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/14/2023
• Initial Date FDA Received: 12/14/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/20/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1