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 12/18/2019

Event Type  malfunction  

Manufacturer Narrative

No product is being returned for evaluation and no lot # has been provided to manufacturer.A follow up report will be sent once the results have been analyzed.

Event Description

Procedure performed: laparoscopic cholecystctomy.Emergency laparoscopic cholecystectomy.Rep was not present, feedback from surgeon post case.Surgeon went to place clip around the cystic duct, however perforated the duct first with tip of the clip applier.Surgeon mentioned that our clip opening is smaller than competitor device, and therefore was difficult to visualise the jaws and get it around the duct to clip.The cystic duct was normal size.They used competitor device to ligate the cystic duct before transecting and removing the gallbladder.Patient status: patient is fine, and completely unaffected.

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.

Event Description

Procedure performed: laparoscopic cholecystctomy emergency laparoscopic cholecystectomy.Rep was not present, feedback from surgeon post case.Surgeon went to place clip around the cystic duct, however perforated the duct first with tip of the clip applier.Surgeon mentioned that our clip opening is smaller than competitor device, and therefore was difficult to visualise the jaws and get it around the duct to clip.The cystic duct was normal size.They used competitor device to ligate the cystic duct before transecting and removing the gallbladder.Patient status: patient is fine, and completely unaffected.

• 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: 9589521
• MDR Text Key: 177620591
• Report Number: 2027111-2020-00317
• Device Sequence Number: 1
• Product Code: FZP
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 03/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2020
• 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: 12/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1