MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES EB015, VOYANT MARYLAND FUSION 37CM, 6/BX; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	EB015
Medical Device Problem Code	Energy Output Problem (1431)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product is being returned for evaluation but lot # is provided.A device history report is to be reviewed by engineering.A final report will be sent once the results have been analyzed.
Event or Problem Description
Procedure performed: spleno pancreatectomy left.During a voyant test with eb015 device.The surgeon made a coagulation cycle on a short vessel.When he removed the device the vessel was bleeding.He repeated two cycles and the coagulation was successful.During the coagulation problem, the surgeon converted to laparotomy from lack of visibility.The patient was obese.Original: pendant un essai voyant avec une pince eb015.Le chirurgien a fait un cycle de coagulation sur un vaisseau court.Lorsqu'il a retire la pince le vaisseau saignait.Il a refait deux cycles et la coagulation a ete reussie.Pendant le probleme de coagulation, le chirurgien a converti en laparotomie du au manque de visibilite.La patiente etait obese.Additional information received by email from applied medical representative on 22july19 no tension was applied to a vessel or bundle that was being sealed.The device was being used for about 50 activations.There was no eschar buildup on the jaws when the insufficient hemostasis was observed.Jaws were cleaned with wet compress about every 30 activations.The surgeon did not really notice an improvement with hemostasis if/when the jaws were cleaned.The insufficient hemostasis was observed in the middle part along the seal site.The jaws were surrounded by fluid (a little bit of blood).There was no generator alarms that interrupted the seal cycle when the insufficient hemostasis was observed.The patient did not exhibit any vascular pathology.The device was not activated on diseased or inflamed tissue.The patient was not given anticoagulation medicine.The sales rep does not know if the conversion to a laparotomy (open from laparoscopic procedure) is due to a malfunction of the device.Additional information received by email from applied medical representative on 26july19 the surgeon told me "yes, i converted in laparotomy because of the voyant didn't coagualate the vessel "corectly"".Intervention: the procedure was terminated with laparotomy.Patient status: no patient injury or illness did occur associated with the complaint event.
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.As the event unit was not returned, testing was unable to be performed and the complainant¿s experience could not be replicated or confirmed.In the absence of the event unit, it is difficult to determine the exact root cause of the event.Applied medical will continue to monitor its vigilance system for trends and take appropriate actions, as necessary, to ensure the performance and safety of its products.
Event or Problem Description
Procedure performed: spleno pancreatectomy left.During a voyant test with eb015 device.The surgeon made a coagulation cycle on a short vessel.When he removed the device the vessel was bleeding.He repeated two cycles and the coagulation was successful.During the coagulation problem, the surgeon converted to laparotomy from lack of visibility.The patient was obese.Original: pendant un essai voyant avec une pince eb015.Le chirurgien a fait un cycle de coagulation sur un vaisseau court.Lorsqu'il a retire la pince le vaisseau saignait.Il a refait deux cycles et la coagulation a ete reussie.Pendant le probleme de coagulation, le chirurgien a converti en laparotomie du au manque de visibilite.La patiente etait obese.Additional information received by email from applied medical representative on 22july19.No tension was applied to a vessel or bundle that was being sealed.The device was being used for about 50 activations.There was no eschar buildup on the jaws when the insufficient hemostasis was observed.Jaws were cleaned with wet compress about every 30 activations.The surgeon did not really notice an improvement with hemostasis if/when the jaws were cleaned.The insufficient hemostasis was observed in the middle part along the seal site.The jaws were surrounded by fluid (a little bit of blood).There was no generator alarms that interrupted the seal cycle when the insufficient hemostasis was observed.The patient did not exhibit any vascular pathology.The device was not activated on diseased or inflamed tissue.The patient was not given anticoagulation medicine.The sales rep does not know if the conversion to a laparotomy (open from laparoscopic procedure) is due to a malfunction of the device.Additional information received by email from applied medical representative on 26july19 the surgeon told me "yes, i converted in laparotomy because of the voyant didn't coagualate the vessel correctly".Intervention: the procedure was terminated with laparotomy.Patient status: no patient injury or illness did occur associated with the complaint event.

• Brand Name: EB015, VOYANT MARYLAND FUSION 37CM, 6/BX
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 8853498
• Report Number: 2027111-2019-00543
• Device Sequence Number: 13532827
• Product Code: GEI
• UDI-Device Identifier: 00607915136956
• UDI-Public: (01)00607915136956(17)201007(30)01(10)1353320
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: D335215
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2019

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: 10/07/2020
• Device Model Number: EB015
• Device Catalogue Number: 101471081
• Device Lot Number: 1353320
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/15/2019
• Supplement Date Received by Manufacturer: 07/15/2019
• Initial Report FDA Received Date: 08/01/2019
• Supplement Report FDA Received Date: 09/23/2019
• 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: GENERATOR EA010