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

Catalog Number ECHO-19

Device Problems Material Twisted/Bent (2981); Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/08/2022

Event Type  malfunction  

Event Description

Purchase department informed us via phone that the customer had complaint about a echo-19 needle (no lot confirmed) needle was very hard to push and also hard to remove from channel.Lots of resistance.Product available.No incident date given."as per cc form": the needle was very hard to push forward (insight and outsight of the scope).Only possible to push the needle forward with resistance.The sheath was damaged.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.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.If the report involves a kink or bend in the needle, where is this located on the device (handle end (proximal end) or patient end (distal end))? n/a, handle end, patient end.Were any other defects (other than the complaint issue) observed on the device prior to return (e.G.Kink)? yes.Please specify if yes.Damage of the sheath.If the device was kinked below the sheath extender, was the kink observed before inserting the device into the scope? n/a, yes, no.If the device is a procore needle, is the device damage located at the notch / core trap? n/a, yes, no.If no, please specify where the damage is located.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 (stomach).If the lungs, which lymph node was being targeted? e.G.4r, 11r, 12l etc.Please describe the size of the intended target site.N.A.If not with the device in question, how was the procedure performed and/or finished? with another needle.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.Did the patient require any additional procedures as a result of this event? no.What intervention (if any) was required? eus.Was the secondary intervention performed during the same procedure as the device failure or was it scheduled for another day? same procedure.Were any other defects observed on the device prior to return (e.G.Kinks, bends, breaks etc.)? yes.If yes, please specify what was observed and where on the device it was observed.Damage of the sheath.What is the scope manufacturer and model number that was used? n.A.Was resistance felt while inserting the device through the scope? no.Was the scope recently serviced / repaired? no.When was the issued with the product noted? on advancement of the sheath/needle.Was the syringe used during the procedure, after the stylet was removed? no.Was difficulty experienced while retracting the needle? no.Was it possible to fully retract the needle into the sheath before removing the device from the patient? yes.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? n.A.Did any section of the device detach inside the patient? no.If yes, please specify: was there difficulty locking the sheath (or needle) in place or slipping experienced during use? no.Was there difficulty in attaching or detaching the device to the accessory channel port on the scope? no.When the needle tip was advanced into the target site was the distal scope position adjusted so as to strain or flex the needle? no.If an ebus procedure did the needle tip hit the cartilage rings of the trachea?.

Manufacturer Narrative

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

Event Description

This follow up mdr is being submitted to capture the lab evaluation: complaint device was returned and evaluated on 04-mar-2022: visual inspection: distal end of the needle examined and no issue observed functional inspection: sheath extender able to advance and retract with no issue.Needle able to advance and retract with no issue.Distal end of the needle examined and no issue observed.Stylet removed with no issue observed, stylet re-inserted with slight resistance.Needle removed and a (proximal) kink observed approximately 15cm from the distal.Needle tip.

Manufacturer Narrative

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

Manufacturer Narrative

Pma/510(k) # (b)(4).Investigation is still pending, a follow-up mdr report will be submitted to include the investigation conclusions.

Event Description

Supplemental follow-up report is being submitted due to the receipt and re-evaluation of the complaint device on (b)(6) 2023 and (b)(6) 2023.

Event Description

Supplemental follow-up report is being submitted due to the completion of the investigation on 19-jun-2023.

Manufacturer Narrative

Device evaluation: 1 unit of echo-19 device of lot number c1857208 involved in this complaint was returned for evaluation, in its original packaging.Lab evaluation: the device related to this occurrence underwent a laboratory evaluation.Visual inspection: - distal end of the needle examined and no issue observed.Functional inspection: - sheath extender able to advance and retract with no issue.- needle able to advance and retract with no issue.- distal end of the needle examined and no issue observed.- stylet removed with no issue observed, stylet re-inserted with slight resistance.- needle removed and a (proximal) kink observed approximately 15cm from the distal needle tip.Document review including ifu review.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 c1857208 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 c1857208.The notes section of the instructions for use, ifu0101 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".There is no evidence to suggest that the customer did not follow the instructions for use (ifu0101).Ncr(b)(4) was raised for the ifu0101 to update the ifu to include instruction to partially remove stylet prior to extending needle into the lesion.(hra) -(b)(4) health risk assessment (hra) ¿ part i initiation information & escalation decision which led to (b)(4) health risk assessment (hra) ¿ part ii initiation information & escalation decision.Based on the outcome of same which included assessment from clinical (medical affairs), engineering and regulatory affairs no further containment actions were required pending this ifu update.(although the customer did not partially remove the stylet prior to advancing the needle this is likely un-related to the issue observed here) root cause review.A definitive root cause could not be determined from the available information.A possible root cause could be attributed to the device being over torqued during the procedure causing the needle to be kinked proximally.Another possible root cause could be attributed to the device becoming kinked on attachment/detachment from scope.Once the needle kinked proximally then this would cause the advancement issue and it is likely due to the proximal kink the needle became caught on the endoscope causing the resistance felt when removing the device from the working channel and causing the damage to the sheath.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 ULTRA ENDOSCOPIC ULTRASOUND NEEDLE
• Type of Device: FCG KIT, NEEDLE, BIOPSY
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• Manufacturer (Section G): COOK IRELAND LTD; o halloran road; national technology park; limerick
• Manufacturer Contact: sinead o'leary ; o halloran road; national technology park; limerick
• MDR Report Key: 13693617
• MDR Text Key: 291499234
• Report Number: 3001845648-2022-00120
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 10827002315201
• UDI-Public: (01)10827002315201(17)210905(10)C1536895
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K083330
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/05/2021
• Device Catalogue Number: ECHO-19
• Device Lot Number: C1536895
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/08/2022
• Event Location: Hospital
• Date Manufacturer Received: 02/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/05/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1