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

Model Number	A3213
Medical Device Problem Codes	Material Twisted/Bent (2981); Patient Device Interaction Problem (4001)
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
Procedure performed: aortic clamping.Event description: stealth clamp scissors during aortic clamping.Type of intervention: unknown.Patient status: patient is ok.
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.
Event or Problem Description
Procedure performed: aortic clamping.Event description: stealth clamp scissors during aortic clamping.Lot number 1528825 taken from lot trace.Additional information received from applied medical representative via email on 10jun25: no, the surgeon did not experience loss of occlusion due to the jaws scissoring.They will not put our stealth in use with the experienced scissoring.They say scissoring damages the vessel and affect patient outcome.The jaws scissored.No damage.But ¿play¿ at the joint of the clamp when the jaws are opened leading to scissoring at the jaw end.Additional information received from applied medical representative via email on 20jun25: both clamps were returned because at first it was not clear and it was thought that the scissoring occurred with both models; so 2 cer¿s were reported right away and 2 clamps got collected and returned.It turned out that the scissoring referred that the a3213 only later.Intervention: left the clamp in place.Patient status: patient is ok.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed that the clamp jaw tips were misaligned.However, the complainant¿s experience could not be replicated as the box lock was not observed to be loose.Applied medical has reviewed the details surrounding the event and related products and is unable to determine the cause of the reported event based on the evaluation of the returned event.Applied medical has performed a historical trend analysis and review of production records and no relevant documentation was identified.

• 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: 22039767
• Report Number: 2027111-2025-00537
• Device Sequence Number: 13027064
• Product Code: DXC
• UDI-Device Identifier: 00607915112691
• UDI-Public: (01)00607915112691
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K950492
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2025

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: A3213
• Device Catalogue Number: 100792801
• Device Lot Number: 1528825
• 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: 05/13/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/16/2025
• Supplement Report FDA Received Date: 09/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• 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