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 03/19/2024

Event Type  malfunction  

Manufacturer Narrative

The event unit has returned to applied medical.A follow up report will be provided following the completion of the investigation.

Event Description

Procedure performed: laparoscopic cholecystectomy event description: complaint 1 of 3: 2024-000792 1 ea ca500 (lot #1502617) (2 non-event ca500 units documented under this complaint), complaint 2 of 3: 2024-000793 1 ea ca500 (lot #1502617), complaint 3 of 3: 2024-000794 1 ea ca500 (lot #1502617), total 3 faulty ca500 units + 2 non-event ca500 units.Hospital: [institution].Product: ca500.From [name] (materials manager): "we had a case with dr.[name] where the clip appliers (ca500) were either misfiring, or not fully clipping the bleeding artery.All 3 that they had malfunction were lot #1502617 that i don¿t see on the recall letter.I also have 2 more of that same lot # that the dr.Is not willing to use after that happened.I have the 2 unopened ones set aside, and the 3 they tried in a biohazard bag along with their outer label packaging.Please advise on how you would like me to proceed with these, and any expediting would be greatly appreciated with the 5 down, i only have one left on the shelf after today.From [name] (am representative): "for 3 faulty ca500 units, they were all used in one lap chole surgery.Clip was not loading and they tried to fire again and clip came out of the jaw.When the clip was fired to the artery, it misfired, and caused bleeding.They were able to stop the bleeding, but the misfire problem caused more bleeding than the surgeon expected during the surgery." products available for return.Additional information received on 11apr2024 from [name] via email "numerous clips were dispensed in total.Total quantity is still unknown, because the surgeon tried several times across multiple devices.Multiple clips from each device experienced this incident event.The clip was never loaded into the jaws prior to the device's insertion/removal through the trocar.Clip was not manually removed as a loaded clip." from or tech: "unloaded clip applier inserted through trocar, clip deployed, clamped clip on common bile duct as tight as possible.Middle section of clip did not clamp down and slid off the end.Several attempts were made.Additionally, clips were falling off when deployed." patient status: no patient injury.Intervention: na.

• 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: 19149416
• MDR Text Key: 341375403
• Report Number: 2027111-2024-00593
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 00607915125318
• UDI-Public: (01)00607915125318(17)260827(30)01(10)1502617
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2024
• 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: 1502617
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2024
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/19/2024
• Date Device Manufactured: 08/28/2023
• 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: APPLIED MEDICAL TROCARS