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 07/12/2023

Event Type  malfunction  

Manufacturer Narrative

The event unit was not returned to applied medical for evaluation.However, applied medical has reviewed the details surrounding the event and is unable to determine the exact root cause of the event.Applied medical received a complaint on august 30, 2023 for this reported incident and has been processed per applied¿s procedures.This medwatch is to follow-up (b)(4).

Event Description

Procedure performed: laparoscopic cholecystectomy.Event description: per the rep, clips are being "eaten" by the clip applier.When the surgeon attempted to fire the device the clips were going back up into the device instead of loading into the jaws.The surgeon tried firing multiple times however they kept "going backwards" back into the device.There was no patient injury.Product from the second complaint is available for return.Additional information was received via email on 20nov2023 from (b)(4).Ca500 lot #1488969 complaint on (b)(6) 2023.Patient information: 65-year-old female, 93 kgs."device would not fire during use, clips backed up in the device.".Additional information was received via email on 21nov2023 from [name], quality improvement facilitator, hospital."this is the same event, it occurred on 7/12 and the medwatch was filed on 7/24." patient status: no patient injury.Intervention: ni.

• 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: 18359037
• MDR Text Key: 331228764
• Report Number: 2027111-2023-00862
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 00607915125318
• UDI-Public: (01)00607915125318(17)260411(30)01(10)1488969
• 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: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/19/2023

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
• Device Catalogue Number: 101474072
• Device Lot Number: 1488969
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/30/2023
• Initial Date FDA Received: 12/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2023
• 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 Age: 65 YR
• Patient Sex: Female
• Patient Weight: 93 KG