MAUDE Adverse Event Report: COOK IRELAND LTD ECHOTIP ULTRA ENDOBRONCHIAL HD ULTRASOUND NEEDLE; FCG KIT, NEEDLE, BIOPSY

Catalog Number ECHO-HD-22-EBUS-P

Device Problems Fracture (1260); Material Twisted/Bent (2981)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/01/2020

Event Type  malfunction  

Manufacturer Narrative

K160229 - 510 k #.Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.

Event Description

As reported to customer relations (customer's internal complaint form provided by dm during phone conversation) "doing ebus procedure.Patient tissue was hard at first, needle bent.We switched out to a second needle.With this one, the needle bent to 90 degrees inside the patient.Able to remove needle without it harming patient or scope.Upon flushing the needle, saline exited from the point where the needle broke, not the tip.Very dangerous for patient, risky for scope.Third needle, it also bent 90 degrees." this file was created to capture the 2nd echo needle used that kinked and subsequently broke.(b)(4) is capturing the 1st and 3rd needle's used that kinked.

Event Description

The investigation was concluded on the 10-feb-2021, this supplement report is being submitted to include the investigation conclusions within section h.The device was evaluated on the 04-mar-2021, this is reflected with section d and h of this report, the investigation was updated to reflect the device evaluation also.

Manufacturer Narrative

K160229 - 510 k # g imdrf code: g04092 - needle.1 unit of lot c1731935 of echo-hd-22-ebus-p was returned opened in its original packaging.It should be noted that this file is related to another complaint file.The device involved in the complaint was evaluated in the laboratory on 04 march 2021.The needle was found to be fractured distally but did not break off completely.Needle able to advance and retract but with difficulty prior to distribution, all echo-hd-22-ebus-p 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 a review of the manufacturing records for echo-hd-22-ebus-p of lot number c1731935 did not reveal any discrepancies that could have contributed to this complaint issue.The review of relevant manufacturing records confirms the failure mode has not previously occurred with the current lot number.Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with lot number c1731935.The notes section of the instructions for use, ifu0060-4, which accompanies this device instructs the user to inspect the device prior to use for any damage: "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 (ifu0060-4).A definitive root cause for the customer complaint could not be determined from the available information.A possible root cause could be attributed to advancement into a hard lesion as per additional information ¿the patient¿s tissue was very hard¿ causing the distal end of the needle to kink and in turn resulted in the needle fracturing when flushing the sample outside the patient.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.

• Brand Name: ECHOTIP ULTRA ENDOBRONCHIAL HD ULTRASOUND NEEDLE
• Type of Device: FCG KIT, NEEDLE, BIOPSY
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 11043232
• MDR Text Key: 251885698
• Report Number: 3001845648-2020-00967
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 10827002534084
• UDI-Public: (01)10827002534084(17)230515(10)C1731935
• Combination Product (y/n): N
• 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: 02/10/2021

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: Health Professional
• Device Expiration Date: 05/15/2023
• Device Catalogue Number: ECHO-HD-22-EBUS-P
• Device Lot Number: C1731935
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2021
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/01/2020
• Event Location: Hospital
• Initial Date Manufacturer Received: 12/03/2020
• Initial Date FDA Received: 12/20/2020
• Supplement Dates Manufacturer Received: 12/03/2020
• Supplement Dates FDA Received: 03/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1