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

Catalog Number ECHO-19

Device Problems Structural Problem (2506); Physical Resistance/Sticking (4012)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/12/2021

Event Type  Injury  

Manufacturer Narrative

The investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

This element presented quality failure during its operation during the procedure (it was not possible to extract specimen).This situation delayed the procedure since it was not possible to extract enough specimen to perform the biopsy.A section of the device did not remain inside the patient¿s body.The patient did require any additional procedures due to this occurrence.The procedure was cancelled and it was scheduled for another day according to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Are images of the device or procedure available? no.Were any other defects (other than the complaint issue) observed on the device prior to return (e.G.Kink)? no.Was gaining access to the target site difficult? no.Was the device used in a tortuous position? no.Was puncture of the target site difficult? no.Please describe the anatomical location of the intended target site (pancreas, stomach, lungs etc.).Pancreas.Please describe the size of the intended target site.33 x 16 mm.If not with the device in question, how was the procedure performed and/or finished? the medical procedure was canceled.Was the device damaged in packaging prior to removal? no.Was the device damaged on removal from packaging? no.Was force required to remove the device? no, but several attempts were made to put the needle inside its cover.Did the patient require any additional procedures as a result of this event? no what intervention (if any) was required? n/a.Was the secondary intervention performed during the same procedure as the device failure or was it scheduled for another day? another day.What is the scope manufacturer and model number that was used? olympus uct 180 1110470.Was resistance felt while inserting the device through the scope? no.When was the issued with the product noted? on advancement of the sheath/needle or on needle retraction? needle retraction.Was the syringe used during the procedure, after the stylet was removed? yes.Was difficulty experienced while retracting the needle? yes.Was it possible to fully retract the needle into the sheath before removing the device from the patient? no.Was the endoscope in a flexed or twisted position at any time during the procedure? no.Was the stylet partially removed when advancing the needle into the target site? no.How many samples were obtained (passes completed) with this needle? no sample.Did any section of the device detach inside the patient? no.

Manufacturer Narrative

Imdrf annex g code: g04092 - needle.The investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

The device was evaluated on the 04-mar-2021, this supplement report is being submitted to reflect this within section d & h of this report.

Manufacturer Narrative

Device evaluation 1 unit of lot c1695384 of echo-19 was returned opened in its original packaging.Lab evaluation the device involved in the complaint was evaluated in the laboratory on 04 march 2021.The needle handle was observed to be broken/fractured clarification was requested as follows; ¿the complaint device has been received and below are some additional questions from cook ireland to aid with the investigation.-was broken handle observed prior returns? please elaborate on the sequence of the events that led to the defect observed?¿ reply was received as follows; ¿regarding your questions, the institution informed us that at the beginning of the procedure, in the first puncture they performed, was the moment where the handle broke.¿ prior to distribution, all echo-19 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-19 of lot number c1695384 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 c1695384.The notes section of the instructions for use, ifu0101-1 which accompanies this device instructs the user to; "visually inspect with particular attention to kinks, bends and breaks.If an abnormality is detected that would prohibit proper working condition, do not use", ¿step 6.Advance needle into lesion.Step 7.Remove stylet from needle by gently pulling back on plastic hub seated in metal fitting of needle handle.Preserve stylet for use if additional cell collection is desired." there is no evidence to suggest that the customer did not follow the instructions for use (ifu0101-1).As per additional information provided the stylet was not partially removed when advancing into the target site as required, the needle tip was not exposed and the blunt stylet tip was.However current ifu does not instruct this, ncr is currently in progress with an action to update the ifu to add this detail.A notification was sent to the product manager to consider retraining at the facility 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 device being used in a flexed or twisted position potentially leading to extra force or manipulation to be used which may have put some strain on the needle handle leading it to break.The break observed would have led to inability to retract the needle.It was noted stylet was not retracted slightly (approx.1 cm), from the luer fitting on the needle handle, to ensure the sharpened distal needle tip is exposed.It may be noted that current ifu does not instruct this, however nc is currently in progress and will document all necessary actions required.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.The procedure was cancelled and it was scheduled for another day complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Clinical input was received (b)(6) 2021, due to the procedure being cancelled and scheduled for another day, severity of 'harm requiring secondary intervention and/or prolonged hospitalisation required' was assigned.This file has been re-assessed as a serious injury report based on clinical input, this will be reflected in this supplement report.

• Brand Name: ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE
• Type of Device: FCG KIT, NEEDLE, BIOPSY
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 11331435
• MDR Text Key: 232741558
• Report Number: 3001845648-2021-00106
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 10827002315201
• UDI-Public: (01)10827002315201(17)230103(10)C1695384
• Combination Product (y/n): N
• PMA/PMN Number: K083330
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 04/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/03/2023
• Device Catalogue Number: ECHO-19
• Device Lot Number: C1695384
• 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: 01/12/2021
• Event Location: Hospital
• Date Manufacturer Received: 01/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention