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

Model Number	EB230
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event device is anticipated to return to applied medical for evaluation.A follow-up report will be provided upon completion of the investigation.
Event or Problem Description
Name of procedure being performed: no surgery was performed.Detailed description of event: when unpacking the voyant clamp, the nurse discovered a hair in the sterile packaging.Not used due to the presence of a hair in the sterile packaging.Additional information received from an applied medical representative via email on 08sep25: the customer has already set aside the pliers for return.Tm will follow up with the customer to see if photos can be taken.Additional information received from an applied medical representative via email on 09sep25: the tm visited the customer, and four [4] images were taken [uploads in attachments].Patient status: na (before use).Type of intervention: the user took another sterile clamp from stock.
Event or Problem Description
Name of procedure being performed: no surgery was performed.Detailed description of event: when unpacking the voyant clamp, the nurse discovered a hair in the sterile packaging.Not used due to the presence of a hair in the sterile packaging.Additional information received from an applied medical representative via email on 08sep25: the customer has already set aside the pliers for return.Tm will follow up with the customer to see if photos can be taken.Additional information received from an applied medical representative via email on 09sep25: the tm visited the customer, and four [4] images were taken.Patient status: na (before use).Type of intervention: the user took another sterile clamp from stock.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation, and photos of the event unit were provided by the complainant.Visual inspection confirmed the presence of a loose hair inside the packaging.Based on the condition of the returned unit and the description of the event, it is likely that the loose hair originated from an operator during the manufacturing process.Applied medical has performed a historical trend analysis and review of production records and no relevant documentations were identified.

• Brand Name: VOYANT® FINE 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: 23034299
• Report Number: 2027111-2025-00763
• Device Sequence Number: 15873638
• Product Code: GEI
• UDI-Device Identifier: 00607915138240
• UDI-Public: (01)00607915138240
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K202818
• 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): 01/15/2026

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: EB230
• Device Catalogue Number: 101476431
• Device Lot Number: 1547163
• 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: 09/01/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/11/2025
• Supplement Report FDA Received Date: 01/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/07/2025
• 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