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

Model Number CA500

Device Problem Migration (4003)

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

Event Date 09/09/2023

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 inguinal hernia repair.Event description: during a revision laparoscopic inguinal hernia repair.Clip applier was being used to ligate several arteries.First clip applier was abandoned after it jammed and the clips were deformed, (sample of deformed clip kept) second device opened and then these clips fell off once the artery was cut.But these clips were not deformed, 3rd device opened from [brand name redacted] and this one worked.This general surgeon uses only our clip applier for all his cases and knows how to use the device.Information received from applied medical representative via email 21sep23: the issue was observed when the first clip was loaded.It occurred again, both devices.5mm applied trocar was used.A clip did not seat into the jaws at all.No pressure 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.The clip was not taken out with device, it was taken out with grasper.Patient status: no clinical impact to the patient intervention: device replacement (competitor's).

• 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: 17890466
• MDR Text Key: 325384712
• Report Number: 2027111-2023-00620
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 00607915125318
• UDI-Public: (01)00607915125318(17)260109(30)01(10)1477354
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K011236
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2023
• 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: 1477354
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/09/2023
• Date Device Manufactured: 01/10/2023
• 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
• Treatment: 5MM APPLIED TROCAR; GRASPER; LAP CAMERA