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

Model Number CA500

Device Problem Loss of or Failure to Bond (1068)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/05/2018

Event Type  malfunction  

Manufacturer Narrative

The event device is anticipated to return.A follow-up report will be provided upon completion of the investigation.

Event Description

Procedure performed: lap chole.The clip applier that was used did not have full clip closer when squeezed plastic to plastic.The product is available to be returned.Please let me know the steps for the facility to return the product.Additional information received via email from account manager on thursday, 6dec2018.No patient injury occurred.Clip fully loaded into the jaws.The vessels were skeletonized prior to firing the clip.The apex of the clip did not close on multiple clips.Patient status: no patient injury occurred.

Event Description

Procedure performed: lap chole.The clip applier that was used did not have full clip closer when squeezed plastic to plastic.The product is available to be returned.Please let me know the steps for the facility to return the product.Additional information received via email from account manager on thursday, 6dec2018.No patient injury occurred.Clip fully loaded into the jaws.The vessels were skeletonized prior to firing the clip.The apex of the clip did not close on multiple clips.Patient status: no patient injury occurred.

Manufacturer Narrative

The event unit was not returned to applied medical for evaluation.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 will continue to monitor its vigilance system for trends and take appropriate actions, as necessary, to ensure the performance and safety of its products.

• Brand Name: CA500, EPIX UNIVERSAL CLIP APPLIER 3/BX
• Type of Device: FZP
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida emprsa; rancho santa margarita CA 92688
• MDR Report Key: 8213616
• MDR Text Key: 132540733
• Report Number: 2027111-2019-00305
• 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,health
• Type of Report: Initial,Followup
• Report Date: 04/30/2019

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: No Information
• Device Model Number: CA500
• Device Catalogue Number: 101471777
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/05/2018
• Initial Date FDA Received: 01/03/2019
• Supplement Dates Manufacturer Received: 12/05/2018
• Supplement Dates FDA Received: 04/30/2019
• Patient Sequence Number: 1