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

Model Number	EB215
Medical Device Problem Codes	Mechanical Problem (1384); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Type of procedure: laparoscopic hysterectomy.Event description: the surgeon used a voyant eb215.He went to grab the fundus o f the uterus and squeezed all the way down.It sounded like something snapped.The jaws were unable to be opened.They replaced the device with a new one.Additional information provided on 28may2025: the doc mentioned that is was mainly squeezing down on a big bite of uterus when they heard it ¿snap¿.That is when it locked up.The jaws were unresponsive after that.They used a grasper to gently slide it off of the tissue.It was toward the beginning of the case.Intervention: they replaced it with a new device.Patient status: fine.
Additional Manufacturer Narrative
The event unit has returned to applied medical.A follow-up report will be provided upon 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 jaws being unable to be opened.Based on the evaluation of the event unit and the description of the event, it is likely that the reported event was caused by bent pull tube, which prevented the jaws from fully opening when the handle is unlatched.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.
Event or Problem Description
Procedure performed: laparoscopic hysterectomy.Event description: the surgeon used a voyant eb215.He went to grab the fundus of the uterus and squeezed all the way down.It sounded like something snapped.The jaws were unable to be opened.They replaced the device with a new one.Additional information provided on 28may2025: the doc mentioned that is was mainly squeezing down on a big bite of uterus when they heard it ¿snap¿.That is when it locked up.The jaws were unresponsive after that.They used a grasper to gently slide it off of the tissue.It was toward the beginning of the case.Intervention: they replaced it with a new device.Patient status: fine.

• 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: 22203713
• Report Number: 2027111-2025-00587
• Device Sequence Number: 17864351
• Product Code: GEI
• UDI-Device Identifier: 00607915139353
• UDI-Public: (01)00607915139353
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2025

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: EB215
• Device Catalogue Number: 101476441
• Device Lot Number: 1533246
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2025
• 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: 05/14/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/13/2025
• Supplement Report FDA Received Date: 09/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/27/2024
• 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
• Patient Sex: Unknown