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

Model Number A1602

Device Problem Difficult to Open or Close (2921)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/11/2022

Event Type  malfunction  

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 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 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.

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
• Type of Device: 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
• MDR Text Key: 288852680
• Report Number: 2027111-2022-00490
• Device Sequence Number: 1
• Product Code: DSS
• UDI-Device Identifier: 00607915115074
• UDI-Public: (01)00607915115074(17)260518(30)01(10)1418686
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K883909
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 06/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 02/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/19/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1