MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES STEALTH® CLAMPS; CLAMP, VASCULAR

Model Number	A3203
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Name of procedure being performed: urologic procedure on the spermatic cord.Event description: parallel clamping no longer possible due to frequent use.It's a service request: original conditions probably not repairable.Please provide a free replacement.Product is already in ame.Or nurse sends the a3203 clamp to sterilization.Routine functionality check according to their standards: sterilization sends it to us with a service request.No patients affected.Intervention: they use their second clamp.Patient status: na.
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.

• Brand Name: STEALTH® CLAMPS
• 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: 24488181
• Report Number: 2027111-2026-00405
• Device Sequence Number: 5105088
• Product Code: DXC
• UDI-Device Identifier: 00607915112721
• UDI-Public: (01)00607915112721
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K950492
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/02/2026

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: A3203
• Device Catalogue Number: 100497301
• 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: 02/04/2026
• Initial Report FDA Received Date: 03/02/2026
• 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