MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES EB217, VOYANT MARYLAND FUSION 23CM; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	EB217
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident device is anticipated to return.A follow-up report will be provided upon completion of investigation.
Event or Problem Description
Procedure performed: open total pancreatectomy.Description: both surgeons were using eb217 without any issues until approximately 2 hours of intervention.At that point, while sealing lymphatic tissue surrounding the splenic artery, the jaws got sticked to the tissue.They opened the jaws and close them again trying to seal and cut again.The tissue would still get sticked making it impossible to separate them from the tissue.In order to be able to separate the tissue from the jaws, they had to use the monopolar pencil and cut the tissue surrounding the jaws.They tried to seal some short vessels around the stomach afterwards and tissue got also sticked.Not to the point where they had to use the monopolar, but they had to rotate the shaft to liberate the tissue.From that point one, they used some competitor device.One hour after using the competitor device (3 hours of intervention more or less), they tried once again using eb217 on mesentery tissue surrounding the small intestine.Again, tissue got sticked and they allowed me recording a couple of videos of that moment.If you want the videos, let me know.They also mentioned the feeling of the trigger changed as the procedure went on, making it a bit harder.The jaws of the tissue were properly clean each time these incidents occurred.Sticking did not lead to bleeding.Patient status: no patient injury or illness occur associated with the complaint event.
Event or Problem Description
Procedure performed: open total pancreatectomy.Description: both surgeons were using eb217 without any issues until approximately 2 hours of intervention.At that point, while sealing lymphatic tissue surrounding the splenic artery, the jaws got stuck to the tissue.They opened the jaws and close them again trying to seal and cut again.The tissue would still get stuck making it impossible to separate them from the tissue.In order to be able to separate the tissue from the jaws, they had to use the monopolar pencil and cut the tissue surrounding the jaws.They tried to seal some short vessels around the stomach afterwards and tissue got also stuck.Not to the point where they had to use the monopolar, but they had to rotate the shaft to liberate the tissue.From that point one, they used some competitor device.One hour after using the competidor device (3 hours of intervention more or less), they tried once again using eb217 on mesentery tissue surrounding the small intestine.Again, tissue got stuck and they allowed me recording a couple of videos of that moment.If you want the videos, let me know.They also mentioned the feeling of the trigger changed as the procedure went on, making it a bit harder.The jaws of the tissue were properly clean each time these incidents occurred.Sticking did not lead to bleeding.Intervention: from that point one, they used some competitor device.Patient status: no patient injury or illness occur associated with the complaint event.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Upon visual inspection, eschar buildup was observed on the sealing surface of the device.Testing was performed on the event unit, which confirmed that the device was sticking to tissue.Based on the condition of the returned unit and the description of the event, the exact root cause of the reported event could not be confirmed.

• Brand Name: EB217, VOYANT MARYLAND FUSION 23CM
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 11681783
• Report Number: 2027111-2021-00457
• Device Sequence Number: 3606522
• Product Code: GEI
• UDI-Device Identifier: 00607915139377
• UDI-Public: (01)00607915139377(17)231109(30)01(10)1399996
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K200598
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2021

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: 11/09/2023
• Device Model Number: EB217
• Device Catalogue Number: 101474492
• Device Lot Number: 1399996
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/31/2021
• Supplement Date Received by Manufacturer: 03/31/2021
• Initial Report FDA Received Date: 04/16/2021
• Supplement Report FDA Received Date: 06/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: EA020 ELECTROSURGICAL GENERATOR