MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES EB215, VOYANT MARYLAND FUSION 37CM, 6/BX; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number EB215

Device Problems No Apparent Adverse Event (3189); Intermittent Energy Output (4025)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/13/2022

Event Type  malfunction  

Manufacturer Narrative

The event device is anticipated to be returned to applied medical for evaluation.A follow-up report will be provided upon completion of investigation.

Event Description

Procedure performed: hiatal hernia event description: the device was used for sealing tissues during the procedure.After coagulation, tissues sticked to the device jaws.The blade seemed not to cut.In consequences, bleedings were observed.They change the device for another one from another company.No changes in heath resulting from the event.Additional information provided by applied medical representative via email 3feb23: only the sealing function was a problem (nothing to blame for the blade, even if the nurses informed the contrary).Then, the surgeon was able to correctly seal from the ¿hernia bag¿ to the ¿halisson skirt¿.After this part of the procedure, the sealing function did not work at all.He doesn¿t remember if the generator was making any sound during the sealing process, but there was no actual coagulation.After many tries and cleaning, the surgeon gave up on the voyant.The surgeon doesn¿t remember the tissue type.It was not a problem of sticking but a coagulation disfunction.He did try to seal multiple times on the same tissue.He used the voyant multiple times before the problem occurred, perhaps for 10 minutes.The disfunction has occurred directly.No sticking during the procedure.The jaws of the device were cleaned once or twice during the procedure.The surgeon did not notice an improvement when the jaws were cleaned.The jaws were not submerged in fluid at any point during activation.The device was not activated on diseased or inflamed tissue or did the patient exhibit any vascular pathology.Intervention: they change the device for another one from another company patient status: good.

Event Description

Procedure performed: hiatal hernia.Event description: the device was used for sealing tissues during the procedure.After coagulation, tissues sticked to the device jaws.The blade seemed not to cut.In consequences, bleedings were observed.They change the device for another one from another company.No changes in heath resulting from the event.Additional information provided by applied medical representative via email 3feb23: only the sealing function was a problem (nothing to blame for the blade, even if the nurses informed the contrary).Then, the surgeon was able to correctly seal from the ¿hernia bag¿ to the ¿halisson skirt¿.After this part of the procedure, the sealing function did not work at all.He doesn¿t remember if the generator was making any sound during the sealing process, but there was no actual coagulation.After many tries and cleaning, the surgeon gave up on the voyant.The surgeon doesn¿t remember the tissue type.It was not a problem of sticking but a coagulation disfunction.He did try to seal multiple times on the same tissue.He used the voyant multiple times before the problem occurred, perhaps for 10 minutes.The disfunction has occurred directly.No sticking during the procedure.The jaws of the device were cleaned once or twice during the procedure.The surgeon did not notice an improvement when the jaws were cleaned.The jaws were not submerged in fluid at any point during activation.The device was not activated on diseased or inflamed tissue or did the patient exhibit any vascular pathology.Intervention: they change the device for another one from another company.Patient status: good.

Manufacturer Narrative

The event unit was returned to applied medical for evaluation without the device key.Testing was performed on the event unit.However, the complainant¿s experience could not be replicated or confirmed, as the incomplete device returned.Applied medical has reviewed the details surrounding the event and related products and is unable to determine the cause of the reported event or confirm that a product malfunction occurred.This event was initially reported based on the description of the event received at complaint intake.However, based on the evaluation of the returned unit, applied medical determined that this event is not reportable as it is unlikely to cause or contribute to death or serious injury as the blood loss was able to be resolved with normal surgical procedural methods.Correction: section h6 (device code) has been corrected from "4025 - intermittent energy output" to "3189 - no apparent adverse event".

• Brand Name: EB215, VOYANT MARYLAND FUSION 37CM, 6/BX
• Type of Device: 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: 16456849
• MDR Text Key: 310429302
• Report Number: 2027111-2023-00360
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00607915139353
• UDI-Public: (01)00607915139353(17)250612(30)01(10)1454494
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K200598
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 04/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EB215
• Device Catalogue Number: 101475463
• Device Lot Number: 1454494
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/13/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: GENERATOR