MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES EB230, VOYANT FINE FUSION, 6/BX; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	EB230
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	05/29/2023
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
Procedure performed: total thyroidectomy event description: information in initial email: unfortunately i had to take that thyroid back to theatre as the patient bled on monday- retrospectively i think i prefer to see the tip of the knife and in thyroid the last 1-2mm is the most important for me.Complaint form information: i followed up with the surgeon regarding the device post-procedure via email where i was informed the patient had to return to surgery later that day due to bleeding.Additional information received by applied medical rep via email on 12jun23: did well and went home according to the plan on time next day¿.Therefore, patient status is discharged.Lot number 1466154.Type of intervention: additional surgery.Patient status: did well and went home according to the plan on time next day.Therefore, patient status is discharged.
Event or Problem Description
Procedure performed: total thyroidectomy.Event description: information in initial email: unfortunately i had to take that thyroid back to theatre as the patient bled on monday- retrospectively i think i prefer to see the tip of the knife and in thyroid the last 1-2mm is the most important for me.Complaint form information: i followed up with the surgeon regarding the device post-procedure via email where i was informed the patient had to return to surgery later that day due to bleeding.Additional information received by applied medical rep via email on 12jun23: did well and went home according to the plan on time next day¿.Therefore, patient status is discharged.Lot number 1466154.Type of intervention: additional surgery.Patient status: did well and went home according to the plan on time next day.Therefore, patient status is discharged.
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 event have been evaluated and were found to be at an acceptable level.

• Brand Name: EB230, VOYANT FINE 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: 17139896
• Report Number: 2027111-2023-00497
• Device Sequence Number: 5696119
• Product Code: GEI
• UDI-Device Identifier: 00607915138240
• UDI-Public: (01)00607915138240(17)250918(30)01(10)1466154
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K202818
• 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): 10/19/2023

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: 09/18/2025
• Device Model Number: EB230
• Device Catalogue Number: 101476431
• Device Lot Number: 1466154
• 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: 05/31/2023
• Supplement Date Received by Manufacturer: 05/31/2023
• Initial Report FDA Received Date: 06/15/2023
• Supplement Report FDA Received Date: 10/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/19/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GENERATOR
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Sex: Unknown