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

Model Number CA500

Device Problem Failure to Align (2522)

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

Event Date 08/10/2023

Event Type  malfunction  

Event Description

Procedure performed: laparoscopic cholecystectomy.Event description: the surgeon began ligating the cystic duct and cystic artery.Surgeon tried to ligate with clip applier, and the first product did not work at all.She did not get any clips from the device.She has to use two other clip appliers to finish the surgery.In the second and third clip appliers, the clips did not worked perfectly.Some of them did not close enough or the clips were bent.They had to use three products to finish the surgery.No clinical impact to the patient.They used three pcs of the product.It is not known which other instruments were used when the complaint event occurred.Information received from applied medical representative via email 15sep23: the clip was on the cystic duct and artery.The clip fully loaded when they could load, sometimes it did not load at all.The trigger was squeezed ¿plastic to plastic".The surgeon fully skeletonized the vessel prior to using the clip applier.The surgeon did not use the clip applier to skeletonize tissue.The clips did not close at all, or sometimes the clip crossed at the tip.Information received from applied medical representative via email on 19sep2023: the clips scissored.Patient status: no patient injury.Intervention: unknown.

Manufacturer Narrative

The event unit is not anticipated to return to applied medical.A follow up report will be provided following the completion of the investigation.

Event Description

Procedure performed: laparoscopic cholecystectomy.Event description: the surgeon began ligating the cystic duct and cystic artery.Surgeon tried to ligate with clip applier, and the first product did not work at all.She did not get any clips from the device.She has to use two other clip appliers to finish the surgery.In the second and third clip appliers, the clips did not worked perfectly.Some of them did not close enough or the clips were bent.They had to use three products to finish the surgery.No clinical impact to the patient.They used three pcs of the product.It is not known which other instruments were used when the complaint event occurred.Information received from applied medical representative via email 15sep23: the clip was on the cystic duct and artery.The clip fully loaded when they could load, sometimes it did not load at all.The trigger was squeezed ¿plastic to plastic".The surgeon fully skeletonized the vessel prior to using the clip applier.The surgeon did not use the clip applier to skeletonize tissue.The clips did not close at all, or sometimes the clip crossed at the tip.Information received from applied medical representative via email on 19sep2023: the clips scissored.Patient status: no patient injury.Intervention: unknown.

Manufacturer Narrative

The event unit was not returned to applied medical for evaluation.As the event unit was not returned, applied medical is unable to determine if the event unit exhibited any non-conformances that could have contributed to the reported event.In the absence of the event unit, it is difficult to determine if the reported event was caused by a manufacturing non-conformance or circumstantial factors at the time of use.Applied medical has reviewed the details surrounding the event and is unable to determine the exact root cause of the event.The probability and criticality of the harm resulting from this event have been evaluated and were found to be at an acceptable level.

• 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: 17830902
• MDR Text Key: 324453220
• Report Number: 2027111-2023-00607
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 00607915125318
• UDI-Public: (01)00607915125318(17)260308(30)01(10)1484025
• Combination Product (y/n): N
• Reporter Country Code: FI
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2023
• 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: 1484025
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1