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

Model Number	EB240
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: abdominoplasty.Event description: dividing the excess skin and fat.The instrument performed well initially.After about one hour the knife got stuck at the outer part of the jaws.They tried to activate and burn potential tissue stuck behind the knife and also forcing the blade lever to come back out but nothing worked.They spent about 15 minutes trying to get it to work.Finally they decided to open a new eb240 and proceed.It performed well and they could finish the surgery.Type of intervention: replaced the device after several attempts to get rid of the tissue stuck behind the knife.Patient status: no clinical impact to the patient.
Additional Manufacturer Narrative
The event unit has returned to applied medical for evaluation.A follow-up report will be submitted upon completion of investigation.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Testing was performed on the event unit, which confirmed the complainant¿s experience of the jaws remaining closed.Engineering observed that the blade was in the forward position and blood and eschar were present in the blade channel.Based on the condition of the event unit, it is likely that the reported event was caused by eschar buildup in the blade and blade channel, resulting in the blade being stuck in the forward position, which prevented the jaws from opening.The instructions for use (ifu) states, ¿buildup of eschar can negatively affect the device¿s sealing and cutting performance¿.Applied medical has performed a historical trend analysis and review of production records and no relevant documentation were identified.
Event or Problem Description
Procedure performed: abdominoplasty.Event description: dividing the excess skin and fat.The instrument performed well initially.After about one hour the knife got stuck at the outer part of the jaws.They tried to activate and burn potential tissue stuck behind the knife and also forcing the blade lever to come back out but nothing worked.They spent about 15 minutes trying to get it to work.Finally, they decided to open a new eb240 and proceed.It performed well and they could finish the surgery.Type of intervention: replaced the device after several attempts to get rid of the tissue stuck behind the knife.Patient status: no clinical impact to the patient.

• Brand Name: EB240, VOYANT OPEN 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: 19731424
• Report Number: 2027111-2024-00747
• Device Sequence Number: 8328073
• Product Code: GEI
• UDI-Device Identifier: 00607915138455
• UDI-Public: (01)00607915138455(17)250116(30)01(10)1473923
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2024

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: 01/16/2025
• Device Model Number: EB240
• Device Catalogue Number: 101474398
• Device Lot Number: 1473923
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2023
• 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: 06/14/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/12/2024
• Supplement Report FDA Received Date: 08/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/28/2022
• 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
• Patient Sex: Unknown