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 Type  malfunction  

Event Description

Procedure performed: cardiovascular intervention event description the event date is unknown a materialovigilance procedure is being drafted by our client: the a1602 device has been experiencing technical problems for several months in the "cardiovascular and thoracic" operating room directed by [surgeon name redacted].The customer will send us his file soon with a maximum of elements.The problem encountered is the slowness of the clip to close.This type of dysfunction has been encountered during several interventions, by several surgeons, according to the nurses.A surgeon [2nd surgeon name redacted] has also contacted the pharmacy to complain about the reference a1602 because he finds the clamping insufficient.I asked to have the lot numbers of the a1602 currently used in the or.The device used is available at the pharmacy for return: it is the one that will be linked to the event form (waiting to be received).Original customer message received from applied medical representative via email on (b)(6), 2023: je me permets de vous contacter pour vous informer d'un évènement indésirable survenu lors de l'utilisation du clip chirurgical stealth de référence a1602 de chez et faisant l'objet d'une matériovigilance.En effet, le clip a présenté une lenteur particulière à se refermer.Ce dysfonctionnement a déjà été constaté à plusieurs reprises et avec des utilisateurs différents.Un clampage insuffisant est également signalé avec l'utilisation de ce clip.Ce problème semble survenir depuis 2 à 3 mois et se produit plusieurs fois par semaine.Ai translation: i am writing to inform you of an adverse event that occurred during the use of the stealth surgical clip, reference a1602, which is the subject of a material safety report.Indeed, the clip was particularly slow to close.This dysfunction has already been noticed on several occasions and with different users.Insufficient clamping is also reported with the use of this clip.This problem seems to have been occurring for 2 to 3 months and happens several times a week.Patient status: no patient injury has been reported.

Manufacturer Narrative

The event unit is not returning to applied medical for evaluation.A follow-up report will be submitted upon completion of investigation.

• 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
• MDR Report Key: 16556506
• MDR Text Key: 311676093
• Report Number: 2027111-2023-00378
• Device Sequence Number: 1
• Product Code: DSS
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A1602
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/20/2023
• 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