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

Catalog Number ECHO-19

Device Problems Fracture (1260); Retraction Problem (1536); Physical Resistance/Sticking (4012)

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

Event Date 12/10/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

After puncturing the lesion the needle didn't retrieve.As per cc form: needle break during the tissue acquisition.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? yes.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.Were any other defects (other than the complaint issue) observed on the device prior to return (e.G.Kink)? no.Please specify if yes.If the device was kinked below the sheath extender, was the kink observed before inserting the device into the scope? n/a.If the device is a procore needle, is the device damage located at the notch / core trap? n/a.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 (pancreas, stomach, lungs etc.).Esophagus.If the lungs, which lymph node was being targeted? e.G.4r, 11r, 12l etc.Please describe the size of the intended target site.2cm.Not with the device in question, how was the procedure performed and/or finished? 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? was the secondary intervention performed during the same procedure as the device failure or was it scheduled for another day? n/a.Were any other defects observed on the device prior to return (e.G.Kinks, bends, breaks etc.)? no.If yes, please specify what was observed and where on the device it was observed.20.What is the scope manufacturer and model number that was used? olympus gf ue 160.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 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? no.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? yes.How many samples were obtained (passes completed) with this needle? 1.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.

Manufacturer Narrative

G imdrf code: g04092 - needle.Investigation is still in progress, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

The device was evaluated on the 25-feb-2021, this supplement report is being submitted to include this information within section d & h.

Event Description

The investigation was concluded on the 22-mar-2021, this supplement report is being submitted to include the investigation conclusions in section h.

Manufacturer Narrative

Imdrf annex g code: g04092 - needle.Device evaluation: 1 x echo-19 of lot # c1455725 was returned to cirl for evaluation open in its original packaging.With the information provided, a physical examination and document based investigation was conducted.Lab evaluation: the device related to this occurrence underwent a laboratory evaluation on 25th february 2021.In summary the following results were observed in the lab evaluation: the needle was found to be broken below the sheath extender.Sheath extender able to advance and retract without issue.Device returned with approximately 3cm of distal end of needle advanced out of sheath.Needle handle advanced to position 8 and needle advanced more out of distal end of sheath.At the same time the stylet observed approximately 4cm out of the needle handle.Needle handle retracted to position 0 but needle did not retract into sheath.At the same time stylet retracted into needle handle.Stylet retracted from device.No issue observed with stylet.Needle retracted from device and break observed below the sheath extender.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 c1455725 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 c1455725.The notes section of the instructions for use, ifu0101-1 which accompanies this device instructs the user to; "this device is used to sample targeted submucosal gastrointestinal lesions through the accessory channel of an ultrasound endoscope", and "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.A definitive root cause for the customer complaint could not be determined as circumstances of use cannot be replicated in the laboratory.It may be possible that damaged occurred during the attachment to scope and potentially causing the needle breakage.A capa has been initiated to document and track the actions taken to investigate and to address kinking or breaking of the sheath at the sheath/sheath extender junction.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
• MDR Report Key: 11285284
• MDR Text Key: 232741552
• Report Number: 3001845648-2021-00058
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 10827002315201
• UDI-Public: (01)10827002315201(17)210219(10)C1455725
• 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: 03/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/19/2021
• Device Catalogue Number: ECHO-19
• Device Lot Number: C1455725
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2021
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/10/2020
• Event Location: Hospital
• Date Manufacturer Received: 01/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Weight: 70