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	Self-Activation or Keying (1557)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: colostomy takedown.Event description: "this is the fourth time i've used open fusion and had a mesentery bleed.It's the same thing each time.In standard tissue for patient disease state.None have been crohn's patients, morbidly obese, on blood thinners, or had challenging tissue otherwise.After one or two activations - the device stops sealing properly.You can see where the fat fused but vessels did not.They weren't large vessels (2-3mm max).The device feels like it's made "cheap", too easy to hit the activation button, when i close the jaws, it feels too smooth, like it's not closing down with enough pressure, and it hasn't performed consistently for me since i agreed to trial it" when asked if bleeding was observed from a specific vessel seal or if there was general oozing observed around the seal area, the response was "the mesentery fat fused ok but the vessel didn't seal at all.There are photos i submitted to the cd team in addition to the device i sent in for testing.Left colic was the vessel." there was no tension applied to a vessel or bundle being sealed.When asked if there was eschar buildup on the jaws when the insufficient hemostasis was observed the response was "no.It happened on the second activation.The jaws were clean.When asked about cleaning the jaws the response was "it wasn't necessary.[surgeon name] didn't activate it enough for eschar build up".The surgeon "stopped using the device when hemostasis wasn't achieved and tied the vessel off - jaws did not have build up".There were no alarms on the generator.Additional information was received via email on 01nov2022 from 01nov2022."i did give you the wrong date.(b)(6) wasn¿t [surgeon name].Lot number is 149045.There were no photos for this one." additional information was received via email on 03nov2022 from [(b)(6)] "we¿ve sent the devices in for testing - yes." event date is unknown.Type of intervention: [surgeon] sutured the vessel that didn't seal.Patient status: doing well.
Additional Manufacturer Narrative
Event unit is anticipated to return 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.However, the complainant¿s experience could not be replicated or confirmed, as the event unit functioned as intended.The event unit met current specifications and there were no visible non-conformances.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.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 blood loss was able to be resolved with normal surgical procedural methods.
Event or Problem Description
Procedure performed: colostomy takedown event description: "this is the fourth time i've used open fusion and had a mesentery bleed.It's the same thing each time.In standard tissue for patient disease state.None have been crohn's patients, morbidly obese, on blood thinners, or had challenging tissue otherwise.After one or two activations - the device stops sealing properly.You can see where the fat fused but vessels did not.They weren't large vessels (2-3mm max).The device feels like it's made "cheap", too easy to hit the activation button, when i close the jaws, it feels too smooth, like it's not closing down with enough pressure, and it hasn't performed consistently for me since i agreed to trial it" when asked if bleeding was observed from a specific vessel seal or if there was general oozing observed around the seal area, the response was "the mesentery fat fused ok but the vessel didn't seal at all.There are photos i submitted to the cd team in addition to the device i sent in for testing.Left colic was the vessel." there was no tension applied to a vessel or bundle being sealed.When asked if there was eschar buildup on the jaws when the insufficient hemostasis was observed the response was "no.It happened on the second activation.The jaws were clean.When asked about cleaning the jaws the response was "it wasn't necessary.[surgeon name] didn't activate it enough for eschar build up (see device photos)".The surgeon "stopped using the device when hemostasis wasn't achieved and tied the vessel off - jaws did not have build up".There were no alarms on the generator.Additional information was received via email on 01nov2022 from [voyant project manager, applied medical] "i did give you the wrong date.September 13th wasn¿t [surgeon name].Lot number is 149045.There were no photos for this one." additional information was received via email on 03nov2022 from [voyant project manager, applied medical] "we¿ve sent the devices in for testing - yes." additional information was received via email on 09nov2022 from [voyant project manager, applied medical] "i don¿t recognize this cer¿.All devices i¿ve sent in are at corporate being tested." additional information was received via email on 14dec2022 from [voyant project manager, applied medical] "the cer number the complaint should be tied to occurred on september 13th.Haven't had the chance to match it up to one of those four by cer number." based on this information it would appear that the complaint that supposedly matches with this one is complaint #(b)(4).Additional information was received via email on 21dec2022 from [voyant project manager, applied medical] when asked to confirm if complaint (b)(4) are the same complaint from the same event, the rep said "yes.That's the same complaint." event date is unknown.Type of intervention: [surgeon] sutured the vessel that didn't seal patient status: doing well.

• 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: 15763864
• Report Number: 2027111-2022-00813
• Device Sequence Number: 12321978
• Product Code: GEI
• UDI-Device Identifier: 00607915138455
• UDI-Public: (01)00607915138455(17)240825(30)01(10)1459045
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2023

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: 08/25/2024
• Device Model Number: EB240
• Device Catalogue Number: 101474615
• Device Lot Number: 1459045
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 09/09/2022
• Supplement Date Received by Manufacturer: 09/09/2022
• Initial Report FDA Received Date: 11/09/2022
• Supplement Report FDA Received Date: 01/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: MEDTRONIC BOVIE AND J&J SUTURE
• Patient Sex: Unknown