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 04/04/2024

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: the surgeon tried to clamp the duct and the cystic artery.So he loaded and clipped the tissues several times by activating the handle.Some clips did not load in the jaws (as a problem which led to the withdrawal of certain batches at the beginning of march) but more seriously, certain clips installed did not hold, probably due to insufficient closure.Some clipped tissus were thin.The use of another device was necessary to have enough clips to hold.Additional information received by applied medical rep via email 10-apr-24: the trigger squeezed was ¿plastic to plastic.The surgeon well skeletonized the vessel prior to using the clip applier, but the clip did not hold on a small bound of tissue.Surgeon did not use the clip applier to skeletonize tissue, they used a monopolar hook and scissors to skeletonize tissue.Apex end did not close.Trocar kii 5 mm advanced fixation was used.Some clips did not load despite pressing the trigger.No pressure applied to the trigger while moving through the trocar.No clip loaded into the jaws prior to the device¿s insertion/removal through the trocar.No clip manually removed as a loaded clip, leaving the feeder exposed.Patient status: no impact for the patient at this time.Intervention: the use of another device was necessary to have enough clips to hold.

• 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: 19160780
• MDR Text Key: 341574895
• Report Number: 2027111-2024-00600
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 00607915125318
• UDI-Public: (01)00607915125318(17)260803(30)01(10)1500975
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: Pharmacist
• Type of Report: Initial
• Report Date: 04/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2024
• 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: 1500975
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/04/2024
• Date Device Manufactured: 08/04/2023
• 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: CLIP APPLIER.; MONOPOLAR HOOK.; SCISSORS.