MAUDE Adverse Event Report: COOK IRELAND LTD ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE; FCG KIT, NEEDLE, BIOPSY

Catalog Number ECHO-HD-3-20-C

Device Problems Loss of or Failure to Bond (1068); Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/09/2020

Event Type  malfunction  

Manufacturer Narrative

510 k #: k142688.Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.

Event Description

Stop puncture.The handle broken in the second puncture.No information regarding patient outcome has currently being reported.Additional details have been requested.

Event Description

This is a follow up report.Investigation was completed on 24-july-2020.Results and conclusions are outlined in section h of this report.Stop puncture.The handle broken in the second puncture.No information regarding patient outcome has currently being reported.Additional details have been requested.

Manufacturer Narrative

K142688 - 510 k number.Device evaluation: 1 unit of unknown lot of echo-hd-3-20-c was returned opened not in its original packaging.Lab evaluation: the device related to this occurrence underwent a laboratory evaluation on 14 july 2020.The needle handle was returned separated from the rest of the device with the needle broken.The needle break occurred within the inner handle.The thumbscrew of the locking ring was returned separately from the device.Locking ring placed on inner handle and thumbscrew tightened.Locking ring unable to be moved when thumbscrew tightened.Document review including ifu review.Prior to distribution, all echo-hd-3-20-c devices are subjected to functional checks and visual inspection to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.As the lot number is unknown a review of manufacturing records could not be performed.The notes section of the instructions for use, ifu0077-4, which accompanies this device instructs the user to inspect the device prior to use: "visually inspect with particular attention to kinks, bends and breaks.If an abnormality is detected that would prohibit proper working condition, do not use".There is no evidence to suggest that the customer did not follow the instructions for use (ifu0077-4).Root cause review: a definitive root cause for the customer complaint could not be determined as circumstances of use cannot be replicated in the laboratory.A possible root cause could be attributed to the inner handle becoming detached from the outer handle due to an excessive force been applied at some point during the procedure; while device was attached to scope.On detachment the needle inside was exposed and subsequently broken as a knock-on effect; possibly due to a sudden torque resulting from the handle detachment.Summary: complaint is confirmed as the failure was verified in the laboratory.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.

• Brand Name: ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE
• Type of Device: FCG KIT, NEEDLE, BIOPSY
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 10242456
• MDR Text Key: 199106706
• Report Number: 3001845648-2020-00401
• Device Sequence Number: 1
• Product Code: FCG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 07/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ECHO-HD-3-20-C
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2020
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/09/2020
• Event Location: Hospital
• Date Manufacturer Received: 06/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1