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

Model Number CA500

Device Problem Insufficient Information (3190)

Patient Problem Perforation of Vessels (2135)

Event Date 07/10/2019

Event Type  malfunction  

Manufacturer Narrative

Ra has received the event device and the product has been assigned to engineering for evaluation.A follow-up report will be sent upon completion of the investigation.

Event Description

Procedure performed: lap chole.Information received from bsn, rn, chor, perioperative services manager, who sent these answers to applied medical implementation specialist, via e-mail on (b)(6) 2019.It is confirmed that the timing of the event occurred during the procedure.The clip applier tore at the artery, and the md was able to cauterize the artery.Regarding patient injury/illness, it's mentioned that the md was able to prevent injury.Additional information received from bsn, rn, chor,perioperative services manager via phone on september 9th, 2019, at 1435.It was confirmed that one of the clips hit the vessel, which is why the artery tore and resulted in the surgeon cauterizing the vessel to stop the bleeding.Event date for this complaint is unknown at this time.The procedure associated with this complaint still needs to be confirmed.Both clip appliers have already been returned to amr and are currently with the qc team waiting to be decontaminated.Additional information received from bsn, rn, chor, tulare perioperative services manager via e-mail on september 10th, 2019 at 1456.The clip that was applied was left in place and then the vessel was cauterized; this is how the case was completed.A new clip applier was not used.Additional information received from bsn, rn, chor, perioperative services manger via e-mail on september 10th, 2019 at 1517.Event date for this complaint has been confirmed as (b)(6) 2019.Patient status: no patient injury occured.

Manufacturer Narrative

The event unit was returned to applied medical for evaluation.Testing was performed on the event unit.However, the complainant¿s experience could not be replicated or confirmed as the event unit met current specifications.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 user's clip application technique.The instructions for use (ifu) states to "ensure that each clip is secure and completely positioned around the tissue being ligated.".

Event Description

Procedure performed: lap chole.Information received from bsn, rn, chor, perioperative services manager, who sent these answers to applied medical implementation specialist, via e-mail on september 6th, 2019.It is confirmed that the timing of the event occurred during the procedure.The clip applier tore at the artery, and the md was able to cauterize the artery.Regarding patient injury/illness, it's mentioned that the md was able to prevent injury.Additional information received from bsn, rn, chor,perioperative services manager via phone on september 9th, 2019, at 1435.It was confirmed that one of the clips hit the vessel, which is why the artery tore and resulted in the surgeon cauterizing the vessel to stop the bleeding.Event date for this complaint is unknown at this time.The procedure associated with this complaint still needs to be confirmed.Both clip appliers have already been returned to amr and are currently with the qc team waiting to be decontaminated.Additional information received from bsn, rn, chor, tulare perioperative services manager via e-mail on september 10th, 2019 at 1456.The clip that was applied was left in place and then the vessel was cauterized; this is how the case was completed.A new clip applier was not used.Additional information received from bsn, rn, chor, perioperative services manger via e-mail on september 10th, 2019 at 1517.Event date for this complaint has been confirmed as (b)(6) 2019.Patient status: no patient injury occured.

• 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
• MDR Report Key: 9131554
• MDR Text Key: 160512767
• Report Number: 2027111-2019-00604
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 00607915125318
• UDI-Public: (01)00607915125318(17)220512(30)01(10)1357490
• Combination Product (y/n): N
• PMA/PMN Number: K011236
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/12/2022
• Device Model Number: CA500
• Device Catalogue Number: 101471777
• Device Lot Number: 1357490
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1