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 12/07/2023

Event Type  malfunction  

Event Description

Procedure performed: unk.Event description: (b)(6) 2023: complaint product family: clip applier, product name: epix universal clip applier, model number: ca500, lot number: unknown.The event occurred during treatment of an unknown procedure.The device had a normal usage in a lap case.The case is reported as unknown.The surgeon reported to the hospital that the clip applier was miss firing leading to tissue tearing.It is unknown if there was any clinical impact to the patient as a result of the event.Another clip applier was used to resolve the situation.It is unknown if there were other instruments being used when the complaint event occurred.It has been reported that the device is being returned in a biobag and so field rep is unable to see lot number for this report.It is unknown if there was a patient injury or illness associated with the complaint event.The status of the patient was reported to have tissue tearing.Additional information was received from field rep."the case was just an appendix.The clip wasn't deploying.The jaws would close but there was no clip in the jaws.The first one worked fine but then none of the subsequent clips worked.It ended tearing the vessel and i had to open a second instrument.Yeah, patient was totally fine.Never really a risk.Just irritating surgically as caused a bit of bleeding." material trace was provided by ama customer relations.See complaint.Patient status: reports that there was tissue tearing.Intervention: another clip applier was used.

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.

• 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: 18360353
• MDR Text Key: 331217807
• Report Number: 2027111-2023-00863
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 12/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2023
• 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?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/10/2023
• 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