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

Model Number	EB240
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	05/14/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Procedure performed: hemorrhoidectomy event description: [surgeon name redacted] was performing a hemorrhoidectomy with eb240.The procedure was finished and device thrown away.Only later the patient discovered to have 8cm thermal burn leading to perforation.This happened over 6 weeks ago and there has been an independent investigation.[name redacted] explained that they need to prove whether this was user error or device failure.The scrub nurse has said that there were no error codes.The patient had an 8cm thermal burn leading to perforation.The procedure was finished and device thrown away.The patient retuned and presented with the symptoms.Additional information received by applied medical rep via email on (b)(6)2024: the patient remains in itu currently.Intervention: the procedure was finished and device thrown away.The patient retuned and presented with the symptoms.Patient status: the patient had an 8cm thermal burn leading to perforation.
Additional Manufacturer Narrative
The event unit is not returning to applied medical for evaluation.A follow-up report will be submitted upon completion of investigation.
Additional 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 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.At this time, applied medical is unable to determine the cause of injury or confirm that a product malfunction occurred.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: hemorrhoidectomy.Event description: [surgeon name redacted] was performing a hemorrhoidectomy with eb240.The procedure was finished and device thrown away.Only later the patient discovered to have 8cm thermal burn leading to perforation.This happened over 6 weeks ago and there has been an independent investigation.[name redacted] explained that they need to prove whether this was user error or device failure.The scrub nurse has said that there were no error codes.The patient had an 8cm thermal burn leading to perforation.The procedure was finished and device thrown away.The patient retuned and presented with the symptoms.Additional information received by applied medical rep via email on 9jul24: the patient remains in itu currently.Intervention: the procedure was finished and device thrown away.The patient retuned and presented with the symptoms.Patient status: the patient had an 8cm thermal burn leading to perforation.

• Brand Name: EB240, VOYANT OPEN 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: 19797814
• Report Number: 2027111-2024-00754
• Device Sequence Number: 17180706
• Product Code: GEI
• UDI-Device Identifier: 00607915138455
• UDI-Public: (01)00607915138455(17)251109(30)01(10)1503799
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2024

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: 11/09/2025
• Device Model Number: EB240
• Device Catalogue Number: 101474398
• Device Lot Number: 1503799
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/22/2024
• Supplement Report FDA Received Date: 09/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/21/2023
• 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: Hospitalization; Required Intervention
• Patient Sex: Unknown