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  

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.This report is to follow-up medwatch #44913040000-2022-8002.

Event Description

Procedure performed: cholecystectomy.Event description: complaint created based on medwatch received by email.Report number 4913040000-2022-8002.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.Product is available for return.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).The issue occurred on the 3rd clip firing.The clip fully loaded into the jaws.The trigger was squeezed plastic to plastic.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.No patient harm.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." patient status: the patient suffered no injury.Intervention: bleeding was controlled with the maryland, and a new clip applier was obtained.

• 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: 15059983
• MDR Text Key: 303820000
• Report Number: 2027111-2022-00660
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/19/2022

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?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/11/2022
• Initial Date FDA Received: 07/19/2022
• 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
• Patient Sex: Female