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

Model Number	EB240
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	11/14/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit is anticipated to return to applied medical for evaluation.A follow-up report will be submitted upon completion of the investigation.
Event or Problem Description
Procedure performed: open colostomy takedown.Event description: the surgeon was attempting to seal tissue and the jaws got stuck to the tissue.When they attempted to remove the jaws, it ripped the tissue and caused extra bleeding.The surgeon completed the surgery using laparoscopic devices and suturing.The bleeding was observed from a specific vessel seal.Additional information cannot be provided.The rep was not present for the case.Patient is fine.Type of intervention: the surgeon completed the surgery using laparoscopic devices and suturing.Patient status: patient is fine.
Event or Problem Description
Procedure performed: open colostomy takedown.Event description: the surgeon was attempting to seal tissue and the jaws got stuck to the tissue.When they attempted to remove the jaws, it ripped the tissue and caused extra bleeding.The surgeon completed the surgery using laparoscopic devices and suturing.The bleeding was observed from a specific vessel seal.Additional information cannot be provided.The rep was not present for the case.Patient is fine.Type of intervention: the surgeon completed the surgery using laparoscopic devices and suturing.Patient status: patient is fine.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Blood and eschar were observed on the jaws.Testing was performed on the event, which confirmed the complainant¿s experience of insufficient hemostasis.After cleaning the jaws, the unit functioned as intended when activated.Based on the condition of the returned unit, it is likely that the reported event was caused by eschar buildup.Applied medical¿s instructions for use (ifu) states that, ¿buildup of eschar can negatively affect the device¿s sealing and cutting performance.¿ the event was initially reported based on the description of the event.However, based on the evaluation of the returned unit and further examination of the event description, applied medical determined that this event is not reportable as it is unlikely to cause or contribute to death or serious injury as the bleeding could be controlled through normal surgical procedures.A correction was made to h1 as there was no patient injury.

• Brand Name: EB240, VOYANT OPEN FUSION, 6 B/X
• 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: 15840565
• Report Number: 2027111-2022-00832
• Device Sequence Number: 5717642
• Product Code: GEI
• UDI-Device Identifier: 00607915138455
• UDI-Public: (01)00607915138455(17)231104(30)01(10)1428147
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/04/2023
• Device Model Number: EB240
• Device Catalogue Number: 101474615
• Device Lot Number: 1428147
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2022
• Supplement Date Received by Manufacturer: 11/16/2022
• Initial Report FDA Received Date: 11/21/2022
• Supplement Report FDA Received Date: 02/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/15/2021
• 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
• Patient Sex: Unknown