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

Model Number	EB240
Medical Device Problem Code	Excessive Heating (4030)
Health Effect - Clinical Codes	Bowel Burn (1756); Burn(s) (1757)
Date of Event	10/15/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The event unit is not returning to applied medical for evaluation, and the lot number was not provided.A follow-up report will be submitted upon completion of the investigation.
Event or Problem Description
Procedure performed: procedure open strangulated femoral hernia repair and small bowel resection event description: (b)(6) 2024 [name redacted] (rsm) advised via phonecall that she was advised the complaint happened ¿a couple of weeks ago¿, it involved a burn to the bowel during a colorectal procedure.The device model is unknown at this stage.(b)(6) 2024 [name redacted] advised the following via email, as notified by [name redacted], nurse unit manager: i have limited information.Product name: voyant open fusion device was used we do not record lot numbers for these devices.Procedure open strangulated femoral hernia repair and small bowel resection date (b)(6) 2024 unfortunately, i am unable to provide a copy of the vhims the patient sustained an iatrogenic skin burn above wound site 6cm x 2cm.The burn evolved of subsequent days requiring x3 returns to theatre for debridement and eventually closure.The sample will not be returned as it wasn't placed to one side.(b)(6) 2024 [name redacted] advised by phone that she believes, based on comments from her conversation with the num that it may be user error: the num asked whether the jaws get warm.[name redacted] thought that while using the voyant the user may have rested the handpiece on the bowel or skin, while the jaws were warm after several activations.She agreed to do some education.Type of intervention: the burn evolved of subsequent days requiring x3 returns to theatre for debridement and eventually closure.Patient status: the patient sustained an iatrogenic skin burn above wound site 6cm x 2cm.The burn evolved of subsequent days requiring x3 returns to theatre for debridement and eventually closure.
Event or Problem Description
Procedure performed: procedure open strangulated femoral hernia repair and small bowel resection.Event description: on (b)(6) 2024: [name redacted] (rsm) advised via phone call that she was advised the complaint happened ¿a couple of weeks ago¿, it involved a burn to the bowel during a colorectal procedure.The device model is unknown at this stage.On (b)(6) 2024: [name redacted] advised the following via email, as notified by [name redacted], nurse unit manager: i have limited information.Product name: voyant open fusion device was used.We do not record lot numbers for these devices.Procedure open strangulated femoral hernia repair and small bowel resection date on (b)(6) 2024.Unfortunately, i am unable to provide a copy of the vhims.The patient sustained an iatrogenic skin burn above wound site 6cm x 2cm.The burn evolved of subsequent days requiring x3 returns to theatre for debridement and eventually closure.The sample will not be returned as it wasn't placed to one side.On (b)(6) 2024: [name redacted] advised by phone that she believes, based on comments from her conversation with the num that it may be user error: the num asked whether the jaws get warm.[name redacted] thought that while using the voyant the user may have rested the handpiece on the bowel or skin, while the jaws were warm after several activations.She agreed to do some education.Type of intervention: the burn evolved of subsequent days requiring x3 returns to theatre for debridement and eventually closure.Patient status: the patient sustained an iatrogenic skin burn above wound site 6cm x 2cm.The burn evolved of subsequent days requiring x3 returns to theatre for debridement and eventually closure.
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-conformance's 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.Applied medical has performed a historical trend analysis and review of production records and no relevant documentations were identified.The probability and criticality of the harm resulting from this event have been evaluated and were found to be at an acceptable level.

• 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: ashleigh mendez ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497135359
• MDR Report Key: 20858666
• Report Number: 2027111-2024-00941
• Device Sequence Number: 8502127
• Product Code: GEI
• UDI-Device Identifier: 00607915138455
• UDI-Public: (01)00607915138455
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2025

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 Model Number: EB240
• Was Device Available for Evaluation?: No
• 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: 11/26/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/05/2024
• Supplement Report FDA Received Date: 01/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Hospitalization; Required Intervention
• Patient Sex: Unknown