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

Model Number CA500

Device Problem Migration (4003)

Patient Problems Exposure to Body Fluids (1745); Pain (1994); Fluid Discharge (2686)

Event Date 08/22/2023

Event Type  Injury  

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 clip applier was used normally.The user noted clips were unstable in the jaws.Two clips were visualized closed, on the duct, before closing the case.The case was completed but the next day the patient was in pain.An ercp was performed since a bile leak was discovered.The patient is recovered.Product is not available for return.Additional information was received via email on 20sep2023 from [name], account manager ii, applied medical the clip was fully loaded into the jaws upon actuation.The trigger was squeezed ¿plastic to plastic".The surgeon did fully skeletonize the vessel prior to using the clip applier.The surgeon did not use the clip applier to skeletonize tissue.Clips appeared to close.Doctor states the clips fell off.Patient status: the patient is recovered.Intervention: an ercp was performed since a bile leak was discovered.

• 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: 17836033
• MDR Text Key: 324503288
• Report Number: 2027111-2023-00610
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 00607915125318
• UDI-Public: (01)00607915125318(17)260201(30)01(10)1478927
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011236
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/28/2023

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?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CA500
• Device Catalogue Number: 101474072
• Device Lot Number: 1478927
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/19/2023
• Date Device Manufactured: 02/02/2023
• 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
• Patient Outcome(s): Required Intervention