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

Model Number CA500

Device Problem Firing Problem (4011)

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

Event Date 06/27/2022

Event Type  malfunction  

Event Description

Procedure performed: laparoscopic cholecystectomy.Event description: the rep was not present during the case.During the case the surgeon used the device to clip the cystic artery.The surgeon initially believed that the artery was successfully clipped but when they went to transect the artery the vessel still bled.The surgeon believed that the clip applied was not tight enough on the vessel.It is unknown if this was the first clip from the device or a subsequent clip.It is unknown which trocar the device was used through.A new ca500 clip applier was used to clip the artery again and was able to successfully stop the bleeding from the vessel.The bleeding was considered minor and no blood transfusion was necessary.No patient injury.Product is available for return.Additional information received on 01jul2022 from [name], applied medical account manager i.The issue occurred on the third clip firing.The clip was fully loaded into the jaws before firing.The trigger was squeezed plastic to plastic.The vessel was fully skeletonized prior to clip application.The surgeon did not use the applier to skeletonize the tissue.The surgeon stated the tip did close but it did not fully close the entire clip upon plastic-to-plastic squeeze.Information from medwatch report number (b)(4) received via email on 11jul2022: provider was performing a cholecystectomy on a patient, and was attempting to clamp the cystic artery when the clip applier failed, and the arterial clip was not clamped appropriately.The provider had to request a new device in order to perform the clamping of the clip correctly.Additional information received on 12jul2022 via email from [name], account manager.That clip was apparent of the lap chole kit and was purchased by account (b)(6).Additional information received on 12jul2022 via email from [name], account manager: lot number confirmed to be 1450652.Additional information received on 15jul2022 via email from [name], interim quality director."the patient suffered no injury.The vessel was completely skeletonized using a maryland dissector before applying the clips.The tips of the clips were approximated but it was later realized (after firing additional clips) that the apex was not closed appropriately.No dissection was performed with the clip applier and the instrument was only used for the clips as i generally use it (clamping down firmly, plastic to plastic).When bleeding occurred i placed a new clip and made sure to clamp firmly, but bleeding continued.Nonfunctioning clips were removed, the bleeding was controlled with the maryland, and a new clip applier was obtained.There was not any significant blood loss, just more than i usually have for a lap chole." additional information received on 09sep2022 via email from [name], director of surgical services, [name of institution].There was only one incident at [name of institution].Patient status: no patient injury.Intervention: bleeding was controlled with the maryland.Used new ca500 device to complete the case.

Manufacturer Narrative

The event unit was returned to applied medical for evaluation.Functional testing was performed on the returned unit, where the remaining clips closed properly when fired.The complainant¿s experience could not be replicated or confirmed as the device passed functional testing.Applied medical has reviewed the details surrounding the event and is unable to determine the cause of the reported event or confirm that a product malfunction occurred.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.The event is not reportable as it is unlikely to cause or contribute to death or serious injury.This report is to follow-up medwatch # (b)(4).Medwatch report #2027111-2022-00660 (documented under complaint # (b)(4)) was initially submitted to follow-up medwatch # (b)(4).However, upon further evaluation of complaint # (b)(4), it was determined that this incident had already been documented under complaint # (b)(4).As complaint # (b)(4) and medwatch #2027111-2022-00660 are being voided, the current medwatch will follow-up medwatch # (b)(4).

• 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: 15503110
• MDR Text Key: 306320658
• Report Number: 2027111-2022-00745
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 00607915125318
• UDI-Public: (01)00607915125318(17)250411(30)01(10)1450652
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/28/2022

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: 1450652
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/11/2022
• Initial Date FDA Received: 09/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/12/2022
• 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: 5 MM ADV TROCAR