MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES EB216, VOYANT MARYLAND FUSION 44CM, 6/BX; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	EB216
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	01/15/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No product is being returned to applied medical for evaluation.A follow-up report will be provided upon completion of investigation.
Event or Problem Description
Procedure performed: sleeve gastrectomy.Event description: sleeve gastrectomy was being performed.Usage was within ifu.No generator error codes were recorded.Surgeon suspects 2 things that may have caused the event: 1- the short gastric arteries were affected by jaw stickiness - may have "pulled off " coagulate when releasing jaw.2- too much tissue tension when doing the dissection.Patient experienced parisplenic hematoma and was readmitted.No re-entry was required.The user resolved the situation by conservative treatment for potential infection and hematoma.Additional information was received via email from [name], applied medical territory manager, on (b)(6) 2023: [surgeon] doesn¿t recall the specifics of the case now as it's been a few weeks since.Intervention: conservative treatment for potential infection and hematoma.Patient status: surgeon reported perisplenic hematoma post-op.Was treated conservatively and no re-entry was required.Currently reported as recovering.
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.The probability and criticality of the harm resulting from this failure have been evaluated and were found to be at an acceptable level.
Event or Problem Description
Procedure performed: sleeve gastrectomy.Event description: sleeve gastrectomy was being performed.Usage was within ifu.No generator error codes were recorded.Surgeon suspects 2 things that may have caused the event: 1- the short gastric arteries were affected by jaw stickiness - may have "pulled off " coagulate when releasing jaw.2- too much tissue tension when doing the dissection.Patient experienced parisplenic hematoma and was readmitted.No re-entry was required.The user resolved the situation by conservative treatment for potential infection and hematoma.Additional information was received via email from [name], applied medical territory manager, on (b)(6) 2023: [surgeon] doesn¿t recall the specifics of the case now as it's been a few weeks since.Intervention: conservative treatment for potential infection and hematoma.Patient status: surgeon reported perisplenic hematoma post-op.Was treated conservatively and no re-entry was required.Currently reported as recovering.

• Brand Name: EB216, VOYANT MARYLAND FUSION 44CM, 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: aaron fulcher ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497135765
• MDR Report Key: 16391943
• Report Number: 2027111-2023-00349
• Device Sequence Number: 14730980
• Product Code: GEI
• UDI-Device Identifier: 00607915139360
• UDI-Public: (01)00607915139360(17)250314(30)01(10)1448175
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/14/2025
• Device Model Number: EB216
• Device Catalogue Number: 101475464
• Device Lot Number: 1448175
• 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: 01/25/2023
• Supplement Date Received by Manufacturer: 01/25/2023
• Initial Report FDA Received Date: 02/16/2023
• Supplement Report FDA Received Date: 04/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2022
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown