MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES VOYANT® MARYLAND FUSION DEVICE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	EB217
Medical Device Problem Codes	Failure to Deliver Energy (1211); Output below Specifications (3004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Type of procedure: bilateral salpingectomy.Event description: event date is unknown.[original french text].Ai translation: the ¿voyant¿ dm did not work (no coagulation).I unplugged it then plugged it back in but it had no effect.We had to open a laparoscopy box so that the surgeon could use the bipolar in it to perform a coagulation procedure.Additional information received by applied medical rep via email on 12may25: the incident was observed after approximately 10 activations.The ready message was displayed on the generator when the device was connected.No alarms.The heard the activation and end tone.Additional information received by applied medical rep via email on 16may25: no bleeding observed due to the incident.The surgeon does not remember whether they activated the blade after hearing the end tone.Patient status: nothing to declare.Intervention: they unplugged and plugged it back but it had no effect.They open a laparoscopy box use a bipolar.Device replacement.
Additional Manufacturer Narrative
The event unit is anticipated to return to applied medical.A follow up report will be provided following the completion of the investigation.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Testing was performed on the event unit, which confirmed the complainant¿s experience of the device failing to deliver rf energy.Based on the evaluation of the event unit and the description of the event, it is likely that the reported event was caused by a loose conductive clip, which resulted in an electrical open.Applied medical has performed a historical trend analysis and review of production records 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, applied medical determined that this event is not reportable as it is unlikely to cause or contribute to death or serious injury.Section d4- additional device information- was updated.Section d4- additional unique device identification (udi) number(s) was updated as well.Also, section h4 was updated.
Event or Problem Description
Procedure performed: bilateral salpingectomy event description: original: le dm "voyant" ne fonctionnait pas (pas de coagulation).Je l'ai débranché puis rebranché mais cela n'a eut aucun effet.Nous avons du ouvrir une boîte de coelioscopie afin que le chirurgien se serve de la bipolaire présente dans celle-ci pour effectuer un geste de coagulation ai translation: the ¿voyant¿ dm did not work (no coagulation).I unplugged it then plugged it back in but it had no effect.We had to open a laparoscopy box so that the surgeon could use the bipolar in it to perform a coagulation procedure.Additional information received by applied medical rep via email on 12may25: the incident was observed after approximately 10 activations.The ready message was displayed on the generator when the device was connected.No alarms.The heard the activation and end tone.Additional information received by applied medical rep via email on 16may25: no bleeding observed due to the incident.The surgeon does not remember whether they activated the blade after hearing the end tone.The lot # was updated per the device logs on 17jul25.(entered by applied medical tm) patient status: nothing to declare intervention: they unplugged and plugged it back but it had no effect.They open a laparoscopy box use a bipolar.Device replacement.

• Brand Name: VOYANT® MARYLAND FUSION DEVICE
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: ashleigh mendez ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497135359
• MDR Report Key: 22142584
• Report Number: 2027111-2025-00569
• Device Sequence Number: 12601752
• Product Code: GEI
• UDI-Device Identifier: 00607915139377
• UDI-Public: (01)00607915139377
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2025

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 Model Number: EB217
• Device Catalogue Number: 101477731
• Device Lot Number: 1533660
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/04/2025
• Supplement Report FDA Received Date: 08/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/10/2024
• 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: GENERATOR.
• Patient Sex: Unknown