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	11/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: unknown event description: hospital: [hospital name]: complaint 1 of 3: (b)(4), complaint 2 of 3: (b)(4), complaint 3 of 3: (b)(4).The product did not work as it should.When the closing movement is made, the ends do not match.See pictures for more detail.No patient was involved as it was detected prior to surgery.Type of intervention: ni.Patient status: no patient injury.
Additional Manufacturer Narrative
The event unit is anticipated to return to applied medical for evaluation.A follow-up report will be provided upon completion of investigation.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed a slight wobble in the box lock and that the jaws were slightly misaligned.Based on the condition of the returned unit, it is likely that the reported event was caused by the box lock being loose, most likely due to wear and tear on the device.Applied medical has performed a historical trend analysis and review of production records and no relevant documentation was identified.This event was initially reported based on the description of the event.However, based on the evaluation of the returned unit, applied medical determined that this event is not reportable as it is unlikely to cause or contribute to death or serious injury as the nonconformity was noticed prior to use.
Event or Problem Description
Procedure performed: [gastric sleeve surgery].Event description: complaint 1 of 3: (b)(4).Complaint 2 of 3: (b)(4).Complaint 3 of 3: (b)(4).The product did not work as it should.When the closing movement is made, the ends do not match.See pictures for more detail.No patient was involved as it was detected prior to surgery.Additional information received from company rep.Via email on 22jan25: they didn't get to use it in the surgery; they tried it before.100% of scissoring occurred.At first glance everything was fine until they tried to clamp.The jaws twisted.Additional information received from applied medical representative via email on 02apr25: according to what i have been told, the first two had problems during the surgery.The third one was tested before surgery and that's when they saw the same problem.Type of intervention: [reopened patient after the procedure].Patient status: [patient was bleeding after the procedure; currently the patient is fine].

• 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: 21193648
• Report Number: 2027111-2025-00324
• Device Sequence Number: 8740940
• Product Code: DXC
• UDI-Device Identifier: 00607915112691
• UDI-Public: (01)00607915112691
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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): 05/23/2025

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: 1491092
• 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: 01/09/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/20/2025
• Supplement Report FDA Received Date: 05/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/22/2025
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown