MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES A3213, CLAMP (SIZE 5-30); CLAMP, VASCULAR

Model Number	A3213
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
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.
Event or Problem Description
Procedure performed: [ni] event description: [hospital: [hospital name] product: a3213 complaint 1 of 4: (b)(4), model #a3213 lot # unknown, complaint 2 of 4: (b)(4), model #a3213 lot # unknown, complaint 3 of 4: (b)(4),model #a3213 lot # unknown, complaint 4 of 4: (b)(4), model #a3213 lot # unknown.[hospital name] the cardiovascular surgeon stopped the rep in the middle of the hospital hallway to state that they had some clamps that were scissoring at the tips.No specific event/case was mentioned.The rep inspected the hospital's seven clamps, and found that four of the clamps were loose.There was no loss of occlusion when using the clamps, the surgeon just had to be more vigilant.In one case, he replaced a clamp with a new one.There are no patient injuries involved with this complaint.Inserts were able to be attached to the clamps.The inserts would not fall off, but they would misalign due to the clamp scissoring.The lot numbers are unknown.The product is available for return.] type of intervention: [surgeon would use a new clamp if needed.] patient status [no patient injury.].
Event or Problem Description
Procedure performed: (b)(6).Event description: product: a3213.Complaint 1 of 4: (b)(4) model #a3213 lot # 1480187, 1ea.Complaint 2 of 4: (b)(4) model #a3213 lot # 1480187, 1ea.Complaint 3 of 4: (b)(4) model #a3213 lot # 1457736 ,1ea.Complaint 4 of 4: (b)(4) model #a3213 lot # 1457736 ,1ea.The cardiovascular surgeon stopped the rep in the middle of the hospital hallway to state that they had some clamps that were scissoring at the tips.No specific event/case was mentioned.The rep inspected the hospital's seven clamps, and found that four of the clamps were loose.There was no loss of occlusion when using the clamps, the surgeon just had to be more vigilant.In one case, he replaced a clamp with a new one.There are no patient injuries involved with this complaint.Inserts were able to be attached to the clamps.The inserts would not fall off, but they would misalign due to the clamp scissoring.The lot numbers are unknown.The product is available for return.Type of intervention: surgeon would use a new clamp if needed.Patient status.No patient injury.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection of the returned unit confirmed misaligned jaws.This confirms the complainant¿s experience of a loose box lock.Based on the condition of the returned unit, it is likely that the reported event was caused by wear and tear on the device.Applied medical has performed a historical trend analysis and review of production records and no trends were identified.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.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.

• Brand Name: A3213, CLAMP (SIZE 5-30)
• Common Device Name: CLAMP, VASCULAR
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: farah azmi ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497138710
• MDR Report Key: 19630167
• Report Number: 2027111-2024-00718
• Device Sequence Number: 12895492
• Product Code: DXC
• UDI-Device Identifier: 00607915112691
• UDI-Public: (01)00607915112691(11)230209(30)01(10)1480187
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2024

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: 1480187
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/27/2024
• Supplement Report FDA Received Date: 10/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/09/2023
• 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