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 Hemorrhage/Bleeding (1888)

Event Date 10/05/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Procedure performed: bypass event description: translation: no clips released.A priori, the surgeon had to urgently clamp a major bleed, and as the clips did not come out, the surgeon was unable to quickly clamp the bleed.Additional information received from applied medical representative via email 12oct23: no consequences for the patient, but very active bleeding during procedure.Had to repeat several times, so bleeding did not stop for several seconds.Patient is good.Procedure being performed was a bypass.Lot number of event unit is 1488877.Patient status: no consequences for the patient, but very active bleeding during procedure.Intervention: had to repeat several times, so bleeding did not stop for several seconds.

Manufacturer Narrative

The event unit was returned to applied medical for evaluation.Testing was performed on the event unit, which confirmed the complainant¿s experience as the unit dry fired.Applied medical has reviewed the details surrounding the event and related products and is unable to determine the cause of the reported event or confirm that a product malfunction occurred.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.Applied medical has issued a voluntary recall of our epix universal clip applier for specific ca500 lots.These ca500 units are being recalled due to a nonconformance that may result in a clip not loading into the jaws after the trigger is actuated.Applied medical has recently implemented manufacturing corrections which are intended to reduce the potential for this type of incident to reoccur.The lot associated with this complaint, #1490523, was included in the recall.

Event Description

Procedure performed: bypass.Event description: translation: no clips released.A priori, the surgeon had to urgently clamp a major bleed, and as the clips did not come out, the surgeon was unable to quickly clamp the bleed.Additional information received from applied medical representative via email 12oct23: no consequences for the patient, but very active bleeding during procedure.Had to repeat several times, so bleeding did not stop for several seconds.Patient is good.Procedure being performed was a bypass.Lot number of event unit is 1488877.Patient status: no consequences for the patient, but very active bleeding during procedure.Intervention: had to repeat several times, so bleeding did not stop for several seconds.

• 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: 18619594
• MDR Text Key: 334257616
• Report Number: 2027111-2024-00368
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 00607915125318
• UDI-Public: (01)00607915125318(17)260406(30)01(10)1488877
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 05/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CA500
• Device Catalogue Number: 101474072
• Device Lot Number: 1488877
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/07/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 2027111-01/26/24-001-R
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention