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

Model Number CA500

Device Problem Failure to Align (2522)

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

Event Type  malfunction  

Manufacturer Narrative

No product is being returned to applied medical for evaluation.A follow-up report will be provided upon completion of investigation.

Event Description

Procedure performed: laparoscopic cholecystectomy event description: information provided by hospital via email 12oct2021: i am getting some adverse feedback from colleagues on this device recently, it appears that the closure is not always secure.Is this a common report that you have? additional information from cer form provided by applied medical representative via email 25oct2021: i met [name] consultant general surgeon, who have experienced the clips scissoring twice.First patient, she used the clip applier for both cystic artery and duct.The clips slightly scissored but she wasn't too concerned as they were secure.She left the clips on patient.No issues post surgery.[separate event] intervention: she left the clips on the patient.Patient status: patients are fine - no issues post surgery.

Event Description

Procedure performed: laparoscopic cholecystectomy.Event description: information provided by hospital via email (b)(6) 2021: i am getting some adverse feedback from colleagues on this device recently, it appears that the closure is not always secure.Is this a common report that you have? additional information from cer form provided by applied medical representative via email (b)(6) 2021: i met [name] consultant general surgeon, who have experienced the clips scissoring twice.First patient, she used the clip applier for both cystic artery and duct.The clips slightly scissored but she wasn't too concerned as they were secure.She left the clips on patient.No issues post surgery.[separate event] intervention: she left the clips on the patient status: patients are fine - no issues post surgery.

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 failure have been evaluated and were found to be at an acceptable level.

• 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: aaron fulcher ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497135765
• MDR Report Key: 12745759
• MDR Text Key: 281750989
• Report Number: 2027111-2021-00702
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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
• Type of Report: Initial,Followup
• Report Date: 12/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CA500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/12/2021
• Initial Date FDA Received: 11/03/2021
• Supplement Dates Manufacturer Received: 10/12/2021
• Supplement Dates FDA Received: 12/09/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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