MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES A1602, 6MM L/L STEALTH CLIP 1/4 F 10/BX; CLIP, VASCULAR

Model Number	A1602
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2022
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 submitted upon completion of investigation.
Event or Problem Description
Procedure performed: unknown.Event description: les clips ne ferment pas /pas de maintien de la prise.Translation: clips do not close / no hold on the clamp.Additional information received from applied medical representative via email on 24-feb-2022: there was no patient injury.3 clips were tried on the patient.The issue was resolved by taking another lot.The clips are available for return.The single-used devices were not reused, they used other clips of the same lot.Type of intervention: change of device.Patient status: no patient injury.
Event or Problem Description
Procedure performed: unknown.Event description: les clips ne ferment pas /pas de maintien de la prise.Translation: clips do not close / no hold on the clamp.Additional information received from applied medical representative via email on 24-feb-2022: there was no patient injury.3 clips were tried on the patient.The issue was resolved by taking another lot.The clips are available for return.The single-used devices were not reused, they used other clips of the same lot.Type of intervention: change of device.Patient status: no patient injury.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Testing was performed on the event unit; however, the customer¿s experience of clips unable to close could not be confirmed or replicated.Applied medical has reviewed the details surrounding the event and related product and is unable to determine the cause of the reported event or confirm that a product malfunction occurred.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.

• Brand Name: A1602, 6MM L/L STEALTH CLIP 1/4 F 10/BX
• Common Device Name: CLIP, VASCULAR
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: aaron fulcher ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497135765
• MDR Report Key: 13847079
• Report Number: 2027111-2022-00490
• Device Sequence Number: 4590130
• Product Code: DSS
• UDI-Device Identifier: 00607915115074
• UDI-Public: (01)00607915115074(17)260518(30)01(10)1418686
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K883909
• 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
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2022

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 Expiration Date: 05/18/2026
• Device Model Number: A1602
• Device Catalogue Number: 101374001
• Device Lot Number: 1418686
• 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: 02/24/2022
• Supplement Date Received by Manufacturer: 02/24/2022
• Initial Report FDA Received Date: 03/22/2022
• Supplement Report FDA Received Date: 06/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/19/2021
• 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