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

Model Number CA500

Device Problem Misfire (2532)

Patient Problem Laceration(s) (1946)

Event Date 04/25/2023

Event Type  malfunction  

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.

Event Description

Procedure performed: laparoscopic gallbladder.Event description: physician unintentionally cut tissue while using clip applier.Patient required open procedure to address the issue.Patient is okay.Product is available for return.Additional information received on 27apr2023 via email from [name], account manager: "first clip applier used misfired four times.Second appplier clip used misfired once.The staff said the clip device transected the biliary tree gallbladder." patient status: patient is okay.Intervention: patient required open procedure to address the issue.

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.This event was initially reported based on the description of the event.However, based on additional information, applied medical determined that this event is not reportable as it is unlikely to cause or contribute to death or serious injury.

Event Description

Procedure performed: laparoscopic gallbladder.Event description: physician unintentionally cut tissue while using clip applier.Patient required open procedure to address the issue.Patient is okay.Product is available for return.Additional information received on 27apr2023 via email from [name], account manager: "first clip applier used misfired four times.Second applier clip used misfired once.The staff said the clip device transected the biliary tree gallbladder.".Additional information received on 17may2023 via email from [name], account manager: "the action involved was in the loading of the clip.The surgeon said the first device would not load a clip.He asked for a second clip applier.The surgeon said the second clip applier would not load a clip.(b)(6) said that neither clip applier cut tissue.(b)(6) said that the surgeon said that the first and second ca500 device would not load a clip but that neither device cut tissue.(b)(6) did not know if the trigger could be pulled as normal.(b)(6) did not know if the clips closed completely.The surgeon ended up opening the patient to finish the procedure.(b)(6) does not plan on returning either device to applied medical.(b)(6) did not want me to trial or handle either device.".Additional information received on 09jun2023 via email from [name], account manager: i don¿t have any additional information on why the surgeon decided to open during the procedure.I was told he tried two clip appliers and then proceeded to open the patient.I was told the case was scheduled as laparoscopic vs open.Patient status: patient is okay.Intervention: patient required open procedure to address the issue.

• 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: 16908477
• MDR Text Key: 314973107
• Report Number: 2027111-2023-00448
• 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
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 10/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2023
• Is this an Adverse Event Report?: Yes
• 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: 04/27/2023
• 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
• Patient Outcome(s): Required Intervention