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 12/07/2023

Event Type  malfunction  

Manufacturer Narrative

The event unit is anticipated to return to applied medical.A follow up report will be provided following the completion of the investigation.

Event Description

Procedure performed: laparoscopic gastrectomy.Event description: [hospital]."when loading and firing clips, clips were not loaded and fired.The device was replaced with the new device." product is available for return.Additional information was received via email on 08dec2023 from [name], amk territory manager "the issue was initially observed when the first clip or a subsequent clip was loaded.It occurred once.Applied ctr03 was used.A clip properly seated into the jaws.Any pressure was not applied to the trigger while moving through the trocar.A clip was not loaded into the jaws prior to the device's insertion/removal through the trocar.A clip was not manually removed as a loaded clip, leaving the feeder exposed.It is unknown whether the trigger could be actuated as normal." patient status: there was no problem with the patient.Intervention: the case was completed with the new device.

Event Description

Procedure performed: laparoscopic gastrectomy.Event description: [hospital] "when loading and firing clips, clips were not loaded and fired.The device was replaced with the new device." product is available for return.Additional information was received via email on (b)(6) 2023 from [(b)(6)], amk territory manager "the issue was initially observed when the first clip or a subsequent clip was loaded.It occurred once.Applied (b)(6) was used.A clip properly seated into the jaws.Any pressure was not applied to the trigger while moving through the trocar.A clip was not loaded into the jaws prior to the device's insertion/removal through the trocar.A clip was not manually removed as a loaded clip, leaving the feeder exposed.It is unknown whether the trigger could be actuated as normal." patient status: there was no problem with the patient.Intervention: the case was completed with the new device.

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.

• 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: 18361015
• MDR Text Key: 331187039
• Report Number: 2027111-2023-00866
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 00607915125318
• UDI-Public: (01)00607915125318(17)260215(30)01(10)1482645
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 04/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2023
• 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: 1482645
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/16/2023
• 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
• Treatment: APPLIED (B)(6) TROCAR.