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 03/11/2022

Event Type  malfunction  

Event Description

Procedure performed: laparoscopic cholecystectomy.Event description: facility: [user facility].The patient's cystic duct was leaking after using ca500 in a procedure.The surgical team had to install a drain to complete the case.Additional information received via email on (b)(6) 2022 from [name], account manager: the cystic duct on the patient was leaking and required to have a drain installed.The patient status is fine.They were discharged and had the drain removed on (b)(6).The hospital reports that there was no damage, the clip was not closed.Additional information received via email on (b)(6) 2022 from [name], account manager: the clip did not load properly during use.The trigger was not closed properly plastic to plastic.The clip didn't close at the apex part.Clips fired and not closed during the case have also been shipped with the device.Additional information received via email on (b)(6) 2022 from [name], account manager: there were no additional procedures required to insert or remove the drain.There was no additional surgery/operation necessary.Product is available for return.Intervention: drain was installed to complete the case and was removed before patient discharge on (b)(6).Patient status: the patient status is fine.

Manufacturer Narrative

The event device is anticipated to be returned to applied medical for evaluation.A follow-up report will be provided upon completion of investigation.

Event Description

Procedure performed: laparoscopic cholecystectomy.Event description: facility: [user facility]: the patient's cystic duct was leaking after using ca500 in a procedure.The surgical team had to install a drain to complete the case.Additional information received via email on 15mar2022 from [name], account manager: the cystic duct on the patient was leaking and required to have a drain installed.The patient status is fine.They were discharged and had the drain removed on (b)(6) 2022.The hospital reports that there was no damage, the clip was not closed.Additional information received via email on 23mar2022 from [name], account manager: the clip did not load properly during use.The trigger was not closed properly plastic to plastic.The clip didn't close at the apex part.Clips fired and not closed during the case have also been shipped with the device.Additional information received via email on 30mar2022 from [name], account manager: there were no additional procedures required to insert or remove the drain.There was no additional surgery/operation necessary.Product is available for return.Intervention: drain was installed to complete the case and was removed before patient discharge on (b)(6) 2022.Patient status: the patient status is fine.

Manufacturer Narrative

The event unit returned to applied medical for evaluation, along with eight (8) non-sterile clips.Visual inspection was performed on the returned unit, the channel support assembly (csa), a metal component in the shaft, was damaged.Additionally six (6) out of the eight (8) returned non-sterile clips to be incompletely closed, which confirms the customer¿s experience of incomplete clip closure.Based on the condition of the returned unit and the description of the event, it is likely that the reported event was caused by the damaged csa and failure to follow the instructions for use (ifu).The csa most likely became caught within the jaws and was crushed during loading through the trocar.Applied medical¿s instructions for use (ifu) states that, "fully compress the trigger against the handle to ensure complete clip formation.Failure to fully close the trigger will result in incomplete clip formation which may lead to bleeding and/or leakage." the probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.

• 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: aaron fulcher ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497135765
• MDR Report Key: 13968242
• MDR Text Key: 288853779
• Report Number: 2027111-2022-00537
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 00607915125318
• UDI-Public: (01)00607915125318(17)240615(30)01(10)1419263
• 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: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2022
• 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: 1419263
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/16/2021
• 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