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

Model Number CA500

Device Problem Migration (4003)

Patient Problem Fluid Discharge (2686)

Event Date 05/23/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Procedure performed: laparoscopic cholecystectomy.Event description: there was a clip applier event involving a bile leak.Patient was reoperated at a separate hospital.Ercp performed.Unknown how leak was repaired.Additional information was received on 02aug2023 from [name], health systems manager associate, applied medical the bleeding/leaking "most likely" occurred due to the clip not occluding.It is unknown if the trigger was actuated plastic to plastic.It is unknown if the ends of the clip were visible around the structure prior to closing the clip.It was a duct that was leaking.Patient is reportedly recovering.It is unknown how the leak was resolved despite it being mentioned that an ercp was performed.Additional information was received on 03aug2023 from [name], health systems manager associate, applied medical it is unknown if the clip had remained on the bile duct or if it had slipped off because the surgeon who initially operated on the patient was not the surgeon who reoperated on the patient.Product is not available for return.Patient status: recovering.Intervention: ercp performed.Unknown how leak was repaired.

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.

Event Description

Procedure performed: laparoscopic cholecystectomy.Event description: there was a clip applier event involving a bile leak.Patient was reoperated at a separate hospital.Ercp performed.Unknown how leak was repaired.Additional information was received on 02aug2023 from [name], health systems manager associate, applied medical the bleeding/leaking "most likely" occurred due to the clip not occluding.It is unknown if the trigger was actuated plastic to plastic.It is unknown if the ends of the clip were visible around the structure prior to closing the clip.It was a duct that was leaking.Patient is reportedly recovering.It is unknown how the leak was resolved despite it being mentioned that an ercp was performed.Additional information was received on 03aug2023 from [name], health systems manager associate, applied medical it is unknown if the clip had remained on the bile duct or if it had slipped off because the surgeon who initially operated on the patient was not the surgeon who reoperated on the patient.Product is not available for return.Patient status: recovering.Intervention: ercp performed.Unknown how leak was repaired.

• 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: 17549734
• MDR Text Key: 321223721
• Report Number: 2027111-2023-00557
• Device Sequence Number: 1
• Product Code: FZP
• 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,Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 12/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CA500
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/27/2023
• 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
• Treatment: EPIX GRASPERS; MONOPOLAR ENERGY; SCISSORS
• Patient Outcome(s): Hospitalization