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

Model Number CA500

Device Problems Loss of or Failure to Bond (1068); Leak/Splash (1354)

Patient Problem Perforation of Vessels (2135)

Event Date 02/19/2020

Event Type  malfunction  

Manufacturer Narrative

The event unit was not returned to applied medical for evaluation and the lot number was not provided.As the event unit was not returned, testing was unable to be performed and the complainant¿s experience could not be replicated or confirmed.In the absence of the event unit, it is difficult to determine the exact root cause of the event.Applied medical has reviewed the details surrounding the event and related product.At this time, applied medical is unable to confirm that a product malfunction occurred.Applied medical will monitor its vigilance systems for any developing trends.This report represents a combined initial and follow-up report.

Event Description

Procedure performed: laparoscopic cholecystectomy.Limited information is available at the time of reporting.Product is the ca500 universal clip applier.Procedure was a laparoscopic cholecystectomy.Event occurred in (b)(6) 2020.I have contacted the surgeon for further details but have not had contact back." additional information was received from account manager, via e-mail on february 24th, 2020: "from what the general coordinator said, "the patient was fine and they were able to finish the case." i still haven¿t spoken to the surgeon to get full details." additional information was received from account manager, via telephone on february 25th, 2020 at 1059: per the general coordinator, the surgeon was "putting clips on and then clips pierced the duct - clips didn't close completely." the rep.Stated that the information provided by the general coordinator was unclear - he is going to confirm with the surgeon directly if incomplete clip closure did occur.They had to complete a cholangiogram.Lot number is unknown and the product is not available for return since it was discarded after use.Additional information was received from account manager, via e-mail on february 27th, 2020: dr.Responded.See below: "i had a significant leak through 2 clips on the cystic duct.Considering the difficulty we were already having with the instrument not passing comfortably through a 5mm trocar." per account manager, this is all the information he will get from the surgeon."sorry, that is all i am getting back from him." additional information was received from account manager, via e-mail on march 9th, 2020: "they were able to finish the case with the clip applier." intervention: finished the case with the clip applier.Patient status: "the patient was fine and they were able to finish the case.".

• 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: wendy kobayashi ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497138059
• MDR Report Key: 9844687
• MDR Text Key: 183856082
• Report Number: 2027111-2020-00427
• Device Sequence Number: 1
• Product Code: FZP
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2020
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/21/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1