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 09/27/2023

Event Type  malfunction  

Event Description

Procedure performed: laparoscopic cholecystecomy.Event description: hospital name: [institution]."we did not attend the surgery, however the doctor is familiar with the ca500 and he has been using it for around 4 months and did not face any issue until now, which means that most likely there is an issue with the handpiece.We did not attend the case, he notified us about what happened: when he was loading the clips, the clips turned out to be crossed over each other as found in the attachment below" no clinical impact was observed on the patient status: good intervention: we replaced the handpiece and retrieved the one he was using.

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 on the event unit, which confirmed the complainant¿s experience of clips scissoring.An improperly welded closure member was also observed.Based on the condition of the returned unit, it is likely that the reported event was caused by the improperly welded closure member.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: laparoscopic cholecystecomy.Event description: hospital name: [hospital]: "we did not attend the surgery, however the doctor is familiar with the ca500 and he has been using it for around 4 months and did not face any issue until now, which means that most likely there is an issue with the handpiece.We did not attend the case, he notified us about what happened: when he was loading the clips, the clips turned out to be crossed over eachother as found in the attachment below".No clinical impact was observed on the patient.Patient status: good.Intervention: we replaced the handpiece and retrieved the one he was using.

• 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: 17890463
• MDR Text Key: 325252694
• Report Number: 2027111-2023-00621
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 00607915125318
• UDI-Public: (01)00607915125318(17)260321(30)01(10)1486039
• Combination Product (y/n): N
• Reporter Country Code: KU
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2023
• 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: 1486039
• 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: 09/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/22/2023
• 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