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

Model Number CA500

Device Problem Loss of or Failure to Bond (1068)

Patient Problem Perforation of Vessels (2135)

Event Date 02/21/2020

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: lap cholecystectomy."surgeon: dr.Product: ca500 universal clip applier.Procedure: lap cholecystectomy.Contacted from account 02/26/20.Event occurred on (b)(6) 2020.I am meeting with surgeon to get event details later this afternoon." additional information received via email on 27feb2020 from account manager "dr.Responded to my email request with the questions, but didn't answer the specific questions." "dr had a clip not close properly and lacerate the cystic duct at the same time." dr.Also states that there have been difficulties with the instrument not passing comfortably through a 5mm trocar.Additional information received via phone on 02mar2020 from account manager during the case dr.Placed a clip around the duct but it did not close the whole way.The surgeon removed the clip from the duct but noticed upon inspection that the duct was lacerated.Dr.Used the same clip applier to clip the duct.After the case the facility disposed of the product.The product is not available for return.Account manager has forwarded a set of follow-up questions to dr.And will attempt to retrieve pictures of the product.Additional information received via phone on 10mar2020 from account manager the rep spoke with dr.About the case.The surgeon noticed that the clip did not close properly and when removed the duct was lacerated.The doctor did not specify what intervention was necessary to treat the laceration.The trocar used was an 5mm ctf03.Patient status: no patient injury.

• 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: 9868835
• MDR Text Key: 184631166
• Report Number: 2027111-2020-00434
• 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: 03/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2020
• 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: 02/26/2020
• 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