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

Model Number	G-3350
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: cardiac surgery.Event description: [hospital name] model g3350 lot 1548224 on (b)(6) 2025 [procedure: cardiac surgery].It was identified that the rubber part of the insert detached from the product during use.The surgeon then checked another insert that had been used for the blockage and found that the same issue had occurred with that insert as well.This indicates that the total quantity of affected products was two units.The procedure was successfully completed by replacing them with new ones.Please note that both detachments were only partial and the rubber parts did not fall into the patient¿s body.Consequently, these issues did not negatively affect the patient.The products in question were disposed of at the hospital.Patient status: no clinical impact.Intervention: these devices were replaced.
Additional Manufacturer Narrative
The event unit is not being returned to applied medical for evaluation.A follow-up report will be provided upon completion of the investigation.

• Brand Name: SOFT / FIBRA® CLAMP INSERT
• 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: 23623643
• Report Number: 2027111-2025-00884
• Device Sequence Number: 10045527
• Product Code: DXC
• UDI-Device Identifier: 00607915111243
• UDI-Public: (01)00607915111243
• 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,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2026

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: G-3350
• Device Catalogue Number: 100063001
• Device Lot Number: 1548224
• Was Device Available for Evaluation?: No
• 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: 11/20/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/21/2025
• Supplement Report FDA Received Date: 05/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/24/2025
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown