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

Model Number CA500

Device Problems Difficult to Insert (1316); Migration (4003)

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

Event Date 06/24/2023

Event Type  malfunction  

Event Description

Procedure performed: treat a common bile duct stone.Event description: [institution] this is a complaint from the market.Please refer to the complaint sheet for investigation.Report from the sales rep the clip was not properly loaded during the procedure.As the jaw slipped through the trocar, the doctor had to apply considerable force to get past the tapered portion of the jaw.The clip itself that fired did not fit the blood vessel tightly, and the clip came off, bleeding from the blood vessel.After bleeding, the bleeding area was burned with an electric scalpel, switched to the device made by [competitor device], and clipped again.The procedure was completed.The related complaint is (b)(4).The facility would like to know whether the same incident has occurred on the same lot as 1433949.Two consecutive cases of similar failures occurred at this facility ((b)(4) ).Initial investigation report the event unit was returned to us.The channel support assembly was deformed.(pic.1) the actual device was inserted the cff03 returned with ca500 and did not feel any resistance.The unit will be returned to amr for further evaluation.Products available for return: 1 device, 1 label patient status: no patient injury intervention: the bleeding area was burned with an electric scalpel, switched to the device made by [competitor device], and clipped again.

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.

Manufacturer Narrative

The event unit was returned to applied medical for evaluation.Functional testing was performed and confirmed the complainant¿s experience of improper loading, dry fire, and incomplete closure.Visual inspection also noted that the distal ramp of the channel support assembly was damaged.Based on the condition of the returned unit, the damaged feeder and channel support assembly are the most likely cause of the incomplete closure.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.

Event Description

Procedure performed: treat a common bile duct stone.Event description: [institution] this is a complaint from the market.Please refer to the complaint sheet for investigation.Report from the sales rep the clip was not properly loaded during the procedure.As the jaw slipped through the trocar, the doctor had to apply considerable force to get past the tapered portion of the jaw.The clip itself that fired did not fit the blood vessel tightly, and the clip came off, bleeding from the blood vessel.After bleeding, the bleeding area was burned with an electric scalpel, switched to the device made by [competitor device], and clipped again.The procedure was completed.The related complaint is (b)(4).The facility would like to know whether the same incident has occurred on the same lot as 1433949.Two consecutive cases of similar failures occurred at this facility (b)(4).Initial investigation report.The event unit was returned to us.The channel support assembly was deformed.(pic.1) the actual device was inserted the cff03 returned with ca500 and did not feel any resistance.The unit will be returned to amr for further evaluation.Products available for return: 1 device, 1 label.Patient status: no patient injury.Intervention: the bleeding area was burned with an electric scalpel, switched to the device made by [competitor device], and clipped again.

• 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: 17553244
• MDR Text Key: 321334644
• Report Number: 2027111-2023-00561
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 00607915125318
• UDI-Public: (01)00607915125318(17)241024(30)01(10)1433949
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2023
• 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: 101471777
• Device Lot Number: 1433949
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/25/2021
• 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: TROCAR (CFF03)