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

Model Number CA500

Device Problem Failure to Align (2522)

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

Event Date 09/08/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Procedure performed: laparoscopic cholecystectomy.Event description: rep was not present for the case.The device experienced a combination of issues.The device would not load clips at times, it would not fire clips, some clips wouldn't close all the way at the apex of the clip, and some clips were said to of scissored.The defective clips that would not close all the way or would experience scissoring were removed.The surgeon went through every available and usable clip in the device and used the same device to complete the case.The patient is fine.The product was discarded.Product not available for return.Patient status: no patient injury intervention: the same device was used to complete the surgery.

Manufacturer Narrative

The event unit was not returned to applied medical for evaluation.As the event unit was not returned, applied medical is unable to determine if the event unit exhibited any non-conformances that could have contributed to the reported event.In the absence of the event unit, it is difficult to determine if the reported event was caused by a manufacturing non-conformance or circumstantial factors at the time of use.Applied medical has reviewed the details surrounding the event and is unable to determine the exact root cause of the event.The probability and criticality of the harm resulting from this event have been evaluated and were found to be at an acceptable level.

Event Description

Procedure performed: laparoscopic cholecystectomy.Event description: rep was not present for the case.The device experienced a combination of issues.The device would not load clips at times, it would not fire clips, some clips wouldn't close all the way at the apex of the clip, and some clips were said to of scissored.The defective clips that would not close all the way or would experience scissoring were removed.The surgeon went through every available and usable clip in the device and used the same device to complete the case.The patient is fine.The product was discarded.Product not available for return.Patient status: no patient injury.Intervention: the same device was used to complete the surgery.

• Brand Name: CA500, EPIX UNIVERSAL CLIP APPLIER 3/BX
• Type of Device: CLIPS, 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: 17836110
• MDR Text Key: 324503978
• Report Number: 2027111-2023-00611
• 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: User Facility,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 01/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2023
• 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
• Date Manufacturer Received: 09/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: TROCAR