MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CA500, EPIX UNIVERSAL CLIP APPLIER 3/BX; CLIP, IMPLANTABLE

Model Number CA500

Device Problem Difficult to Insert (1316)

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

Event Date 02/08/2024

Event Type  malfunction  

Event Description

Procedure performed: hernia surgery.Event description: i observed a tep hernia case with dr.[name] where a clip applier was not used.After the case, his assistant mentioned that our clip applier sometimes gets stuck in our 5mm trocars and they have to push it through.Additional information provided by [name] on 1apr2024 via email.Did the device jam while on a vessel? no.Did the device jam in the open or closed position? if jammed device with torn structure.Device dragged while going through trocar.No issues with usage once inside the abdomen.Patient status: no patient injury.Intervention: ni.

Manufacturer Narrative

The event unit is not anticipated to return to applied medical.A follow up report will be provided following the completion of the investigation.

• Brand Name: CA500, EPIX UNIVERSAL CLIP APPLIER 3/BX
• Type of Device: CLIP, IMPLANTABLE
• 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: 19130472
• MDR Text Key: 341392371
• Report Number: 2027111-2024-00577
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011236
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/17/2024

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
• Device Operator: Health Professional
• Device Model Number: CA500
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/12/2024
• Initial Date FDA Received: 04/18/2024
• 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
• Treatment: 5MM TROCARS.