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

Model Number CA500

Device Problem Failure to Fire (2610)

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

Event Date 12/08/2023

Event Type  malfunction  

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.

Event Description

Procedure performed: laparoscopic sleeve gastrectomy event description: dr was trying to load the clip.When dr tried to load the clip, he pressed the handle but no clip was loaded into the jaws.He then noticed the handle did not open back easily, when it opened again, he tried pressing it again to laod a clip, also no clip was loaded and the handle got stuck again.Patient status: fine intervention: replaced it.

Manufacturer Narrative

Applied medical has issued a voluntary recall of our epix universal clip applier for specific ca500 lots.These ca500 units are being recalled due to a nonconformance that may result in a clip not loading into the jaws after the trigger is actuated.Applied medical has recently implemented manufacturing corrections which are intended to reduce the potential for this type of incident to reoccur.The lot associated with this complaint, #(b)(4) , was included in the recall.

Event Description

Procedure performed: laparoscopic sleeve gastrectomy.Event description: dr was trying to load the clip.When dr tried to load the clip, he pressed the handle but no clip was loaded into the jaws.He then noticed the handle did not open back easily, when it opened again, he tried pressing it again to laod a clip, also no clip was loaded and the handle got stuck again.Patient status: fine.Intervention: replaced it.

• 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: 18369805
• MDR Text Key: 331073573
• Report Number: 2027111-2023-00876
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 00607915125318
• UDI-Public: (01)00607915125318(17)260207(30)01(10)1479774
• Combination Product (y/n): N
• Reporter Country Code: LE
• PMA/PMN Number: K011236
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/20/2023

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
• Device Catalogue Number: 101474072
• Device Lot Number: 1479774
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/20/2023
• Date Device Manufactured: 02/08/2023
• 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