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

Model Number CA500

Device Problem Failure to Align (2522)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/16/2021

Event Type  malfunction  

Event Description

Procedure performed: lap.Chol.Event description: [(b)(6) translation] i find the clip applier not so good, it inserts very difficult into the trocar and you can't move it smoothly in the trocar.Clip doesn't always close well, sometimes the legs cross.The experience certainly isn't better only + is a little longer clip.Additional information received from applied medical representative via email on (b)(6) 2021: no pressure was applied to the trigger while moving through the trocar.There was no clip loaded into the jaws prior to the device's insertion or removal.The surgeon held the blue handle in his hand when the device was inserted into the trocar.The trocar used in combination with the clip applier is applied medical's ctf03.Scissoring of the clip occurs frequently, at least 1 out of 2 interventions they see one or more clips scissoring and/or not closed at the end of the legs of the clip.No tissues or structures were damaged when the clips scissored, but the clip legs are not aligned, so not a secure closure of the vessel or biliary structures.The issue was resolved by placing an additional clip, which is sometimes only possible after removing the scissoring clip.The clip applier used in the surgery of (b)(6) 2021, will be returned, along with a scissored clip (was cut out by the surgeon to prove the issue).Intervention: the issue was resolved by placing an additional clip.Patient status: unknown.

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: lap.Chol.Event description: [translation] i find the clip applier not so good, it inserts very difficult into the trocar and you can't move it smoothly in the trocar.Clip doesn't always close well, sometimes the legs cross.The experience certainly isn't better only + is a little longer clip.Additional information received from applied medical representative via email on 23-dec-2021: no pressure was applied to the trigger while moving through the trocar.There was no clip loaded into the jaws prior to the device's insertion or removal.The surgeon held the blue handle in his hand when the device was inserted into the trocar.The trocar used in combination with the clip applier is applied medical's ctf03.Scissoring of the clip occurs frequently, at least 1 out of 2 interventions they see one or more clips scissoring and/or not closed at the end of the legs of the clip.No tissues or structures were damaged when the clips scissored, but the clip legs are not aligned, so not a secure closure of the vessel or biliary structures.The issue was resolved by placing an additional clip, which is sometimes only possible after removing the scissoring clip.The clip applier used in the surgery of (b)(6) 2021, will be returned, along with a scissored clip (was cut out by the surgeon to prove the issue).Additional information received from applied medical representative via email on 04-jan-2022: no injury nor illness.Just to put some extra clips which were well placed on the structures.Intervention: the issue was resolved by placing an additional clip.Patient status: no injury nor illness.Just to put some extra clips which were well placed on the structures.

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.

• 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: 13122659
• MDR Text Key: 286596624
• Report Number: 2027111-2021-00806
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 02/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2021
• Is this an Adverse Event Report?: No
• 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?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/17/2021
• 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: 5MM TROCAR (CTF03)