MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES EB210, VOYANT 5MM FUSION 37CM, 6/BX; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	EB210
Medical Device Problem Codes	Energy Output Problem (1431); Self-Activation or Keying (1557)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit is anticipated to return to applied medical for evaluation.A follow-up report will be provided upon completion of investigation.
Event or Problem Description
Event description: hospital: [hospital name].Product: eb210."doctor inserted the eb210 through 5mm applied medical trocar.Upon sealing the first seal on the mesosalpinx tissue and transecting the tissue successfully right after, subsequent 2nd, 3rd, and 4th seals had no reactions within the tissue.It did not appear like the energy has been delivered to the tissue although the generator functioned normally with the start and end tone ringing.The doctor tried the seal again, and it seemed like there was little to no energy delivered to the tissue.Doctor proceeded to transect the tissue regardless and the bleeding occurred.Physician then asked for [competitor product] and successfully finished the surgery.Doctor noted that throughout the remainder of the procedure, the doctor was able to finish the surgery with successful seals with ligasure unlike applied medical's voyant; however, it did seem like [competitor product] was also not working as well as usual." product available for return.Type of intervention: the case was completed with [competitor product].Patient status: no patient injury.
Event or Problem Description
Procedure performed: total laparoscopic hysterectomy.Event description: hospital: [hospital name].Product: eb210."doctor inserted the eb210 through 5mm applied medical trocar.Upon sealing the first seal on the mesosalpinx tissue and transecting the tissue successfully right after, subsequent 2nd, 3rd, and 4th seals had no reactions within the tissue.It did not appear like the energy has been delivered to the tissue although the generator functioned normally with the start and end tone ringing.The doctor tried the seal again, and it seemed like there was little to no energy delivered to the tissue.Doctor proceeded to transect the tissue regardless and the bleeding occurred.Physician then asked for [competitor product] and successfully finished the surgery.Doctor noted that throughout the remainder of the procedure, the doctor was able to finish the surgery with successful seals with ligasure unlike applied medical's voyant; however, it did seem like [competitor product] was also not working as well as usual." product available for return.Additional information received from via email on 30may2024 no the generator was not making any alarm tones during the procedure.General oozing was observed around the seal/transection area between the falopian tube and the round ligament in the "mesosalpinx".The initial seal/transection was near the fembria of the falopian tube and then additional seals were more medial to the uterus in the mesosalpinx.This tissue is typically a more avascular and thinner tissue but can vary in size from patient to patient.In this case the tissue did not seem enlarged or inflamed.No tension was applied to the tissue during or after the seal/transection of the tissue.After the initial activation (seal number 1) the surgeon began to notice insufficient sealing and the subsequent activations were equally insufficient.No the device was just removed from the packaging and inserted into the patient.Insufficient hemostasis was observed on the very first seal.The device was only activated 5-6 times before the surgeon requested another device (ligasure) to be open.When removed there was minimal eschar on the outside of the jaws but nothing on the electrodes.There were no alarm tones during the sealing of tissue.Both physicians did not mention or know of any pathological concerns from this patient.To the physician's knowledge the patient did not have any disease / inflammation that would have caused concerns for vessel sealing.Type of intervention: the case was completed with [competitor product].Patient status: no patient injury.
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 confirmed as the 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 has occurred.A historical trend analysis and review of production records was performed, and no relevant documentation was identified.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.Correction to section b5: updated to reflect procedure performed.

• Brand Name: EB210, VOYANT 5MM 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
• Manufacturer Contact: farah azmi ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497138710
• MDR Report Key: 19393802
• Report Number: 2027111-2024-00663
• Device Sequence Number: 6776866
• Product Code: GEI
• UDI-Device Identifier: 00607915138424
• UDI-Public: (01)00607915138424(17)260409(30)01(10)1486323
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2024

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: 04/09/2026
• Device Model Number: EB210
• Device Catalogue Number: 101475457
• Device Lot Number: 1486323
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/24/2024
• Supplement Report FDA Received Date: 09/06/2024
• 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: 5MM APPLIED MEDICAL TROCAR.
• Patient Sex: Unknown