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

Model Number CA500

Device Problem Difficult to Insert (1316)

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

Event Date 06/20/2023

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: cholecystectomy.Event description: 10.And 20.June - lot 1477357 cannot (strong) be passed through the 5 mm trocar.Information received from applied medical representative via email 4jul23: no information from op manager regarding patient status.The event happened during insertion.No pressure was applied to the trigger during insertion through the trocar.A clip was not loaded in the jaws upon clip applier insertion and/or removal.Trocar not available for return, it was discarded after the procedure.Information received from applied medical representative via email 11jul23: when the ca500 is inserted into our 5mm trocar, you will feel some resistance.The resistance is often so strong that the ca500 goes very hard through our 5mm trocar.Patient status: no patient injury has been reported.Intervention: device replacement.

Manufacturer Narrative

The event unit was returned to applied medical for evaluation.Visual inspection confirmed that the distal ramp of the channel support assembly (csa) was damaged.Functional testing was performed on the event unit, which confirmed the complainant¿s experience of resistance while inserting the event clip applier through a representative trocar.Based on the condition of the returned unit, it is likely that the reported event was caused by the csa distal ramp becoming caught in the jaws and crushed during loading through the trocar.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: cholecystectomy.Event description: 10.And 20.June - lot 1477357 cannot (strong) be passed through the 5 mm trocar.Information received from applied medical representative via email 4jul23: no information from op manager regarding patient status.The event happened during insertion.No pressure was applied to the trigger during insertion through the trocar.A clip was not loaded in the jaws upon clip applier insertion and/or removal.Trocar not available for return, it was discarded after the procedure.Information received from applied medical representative via email 11jul23: when the ca500 is inserted into our 5mm trocar, you will feel some resistance.The resistance is often so strong that the ca500 goes very hard through our 5mm trocar.Patient status: no patient injury has been reported.Intervention: devie replacement.

• 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: 17337894
• MDR Text Key: 319943315
• Report Number: 2027111-2023-00522
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 00607915125318
• UDI-Public: (01)00607915125318(17)260116(30)01(10)1477357
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2023
• 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: 1477357
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/17/2023
• 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: CFF12