MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES VOYANT MARYLAND FUSION DEVICE WITH SINGLE-STEP ACTIVATION; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	EB213
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Event or Problem Description
Procedure performed: gastric sleeve surgery.Event description: hospital: [hospital name].Doctor mentioned that he was doing a procedure for a patient about a month ago and they did not realize that something happened to the patient until after the treatment.The patient was bleeding and they had to reopen the patient after the procedure.Type of intervention: reopened patient after procedure.Patient status: patient was bleeding after procedure; currently the patient is fine.
Additional Manufacturer Narrative
The event unit is not anticipated to return to applied medical for evaluation.A follow-up report will be submitted upon completion of the 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 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 documentation was identified.The probability and criticality of the harm resulting from this event have been evaluated and were found to be at an acceptable level corrections were performed for sections b2 and h6.
Event or Problem Description
Procedure performed: gastric sleeve surgery.Event description: doctor mentioned that he was doing a procedure for a patient about a month ago and they did not realize that something happened to the patient until after the treatment.The patient was bleeding and they had to reopen the patient after the procedure.Additional information: bleeding was not observed immediately after the jaws were removed from tissue.Bleeding did not occur until after the procedure.The bleeding was resolved by opening and then sewing the patient back up.The tissue type/anatomy and thickness/size being sealed when the bleeding was observed was obese.The doctor said the patient had a bleeding disorder.The jaws of the device were cleaned during the procedure.Type of intervention: reopened patient after the procedure.Patient status: patient was bleeding after the procedure; currently the patient is fine.

• Brand Name: VOYANT MARYLAND FUSION DEVICE WITH SINGLE-STEP ACTIVATION
• 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: 21149863
• Report Number: 2027111-2025-00318
• Device Sequence Number: 21147927
• Product Code: GEI
• UDI-Device Identifier: 00607915140809
• UDI-Public: (01)00607915140809
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K222284
• 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): 05/28/2025

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: EB213
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/14/2025
• Supplement Report FDA Received Date: 05/28/2025
• 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