MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES FIBRA / FIBRA® CLAMP INSERTS; CLAMP, VASCULAR

Model Number	G-6155
Medical Device Problem Code	Unintended Ejection (1234)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit is anticipated to return to applied medical evaluation.A follow-up report will be sent upon completion of investigation.
Event or Problem Description
Procedure performed: cardiac surgery.Event description: [distributor name] [hospital name]: model: g6155 lot: 1422015.On (b)(6) 2025 [procedure: cardiac surgery].It was reported that the insert in question could not be properly attached to the clamp.At the beginning of the procedure, a nurse set up the insert to a clamp, but it appeared that the insert could not be properly secured.As a result, the surgeon noticed a loss of occlusion or sensed something was wrong during use.An attempt was made to reattach the insert to the clamp, but it was unsuccessful and the insert was replaced with a new one.The procedure was successfully completed using the new insert.The product in question will be returned to you for the investigation.Please investigate the possible root cause.The hospital has requested the investigation report.There was no clinical impact to the patient.Patient status no patient injury indicated intervention: the insert was replaced.The procedure was successfully completed using the new insert.
Event or Problem Description
Procedure performed: cardiac surgery.Event description: [distributor name] [hospital name]: model: g6155 lot: 1422015.On (b)(6) 2025 [procedure: cardiac surgery].It was reported that the insert in question could not be properly attached to the clamp.At the beginning of the procedure, a nurse set up the insert to a clamp, but it appeared that the insert could not be properly secured.As a result, the surgeon noticed a loss of occlusion or sensed something was wrong during use.An attempt was made to reattach the insert to the clamp, but it was unsuccessful and the insert was replaced with a new one.The procedure was successfully completed using the new insert.The product in question will be returned to you for the investigation.Please investigate the possible root cause.The hospital has requested the investigation report.There was no clinical impact to the patient.Patient status no patient injury indicated.Intervention: the insert was replaced.The procedure was successfully completed using the new insert.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed that the distal and proximal buttons of both inserts were damaged.Based on the condition of the returned unit, it is likely that the reported event was caused by the user pressing down directly on the insert during installation, resulting in damage to the buttons.The instructions for use (ifu) states "confirm that inserts are compatible and have been securely attached to jaws prior to clamping.Using clamps without inserts may cause trauma to the vessel tissue.Failure to confirm if inserts remain securely attached to the clamp throughout the entirety of the procedure may result in unintended material left in the patient.Observe for leaks to ensure proper occlusion." applied medical has performed a historical trend analysis and review of production records and no relevant documentations were identified.Corrected section g2.Removed company representative in this section of this report.

• Brand Name: FIBRA / FIBRA® CLAMP INSERTS
• Common Device Name: CLAMP, VASCULAR
• 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: 22745393
• Report Number: 2027111-2025-00685
• Device Sequence Number: 8322513
• Product Code: DXC
• UDI-Device Identifier: 00607915111274
• UDI-Public: (01)00607915111274
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K883790
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2026

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 Expiration Date: 07/08/2026
• Device Model Number: G-6155
• Device Catalogue Number: 100063301
• Device Lot Number: 1422015
• 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: 07/31/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/07/2025
• Supplement Report FDA Received Date: 01/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/09/2021
• 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