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 03/07/2024

Event Type  malfunction  

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: videolaparoscopic cholecystectomy surgeries event description: translation: applied company's epix linear suturing machine ref.Ca500 did not dispensed the clips preloaded in the'applicator during the surgical procedure.Additional information received on (b)(6) 2024: translation 1.There was no injury to the patient on whom the device was used.2.The patient has reported no health problems attributable to the use of the device.3.The problem was solved by opening other devices.4.The intervention time was extended by 10/15 minutes due to opening and using other devices and repeating the clipping manoeuvre.5.Clipping devices were used for videolaparoscopic cholecystectomy operations 6.Other similar devices were opened and used (when possible with different lot) to finish the surgery.7.We have the same lot of devices available as those being reported.Those used were discarded patient status: no health problems patient status: there was no injury on the patient on whom the device was used.Intervention: the problem was solved by opening other devices.

• 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: 19140186
• MDR Text Key: 341459924
• Report Number: 2027111-2024-00588
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 00607915125318
• UDI-Public: (01)00607915125318(17)260419(30)01(10)1489896
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: Nurse
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 04/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2024
• 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: 1489896
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/18/2024
• Date Device Manufactured: 04/20/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 2027111-01/26/24-001-R
• Patient Sequence Number: 1