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

Catalog Number ECHO-19

Device Problem Fracture (1260)

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

Event Date 12/21/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

User advanced the device through endoscopy to desired position and pulled the stylet while found out the tip of needle abnormal, then user retracted the stylet into needle and retracted the device from patient.User changed another same device to complete the procedure.Device was returned and evaluated on the 27-jan-2021, distal needle break noted.

Manufacturer Narrative

Imdrf annex g code: g04092 - needle.Device evaluation: 1 unit of lot c1703051 of echo-19 was returned opened in its original packaging.The device involved in the complaint was evaluated in the laboratory on 27 jan 2021.The distal tip of the needle was observed to be broken.A proximal kink was observed below the sheath extender an additional file was opened in relation to the proximal kink as it could not be linked to the complaint issue.Clarification was requested as follows; ¿the above mentioned damage (proximal needle kink) was observed during the lab evaluation at cook ireland and we would like to know if it was observed (which means the additional pr to be opened) or as a result of returns (which will mean the new pr that you will open can be cancelled).¿ reply was received as follows; ¿customer confirmed no needle kink observed during procedure, and it may occur during transportation.¿ as a result of the above file was cancelled.Clarification was also requested as follows; ¿please see below snippets from q.18 and q.20 of the additional questions.The answer to q.18 would indicate that no needle puncture was attempted while the answer to q.20 would indicate that a biopsy was obtained which would indicate a puncture was competed.Can you please clarify if a puncture was attempted or not please?¿ reply was received as follows; ¿customer confirmed there is no difficulty during penetration.And the information has been updated in tw accordingly¿ further clarification was requested as follows; ¿the lab evaluation of the device returned in relation to this complaint observed that the distal needle tip was broken (see photos below).Can you please ask if the broken needle tip had been retrieved? if so, by what means?¿ reply was received as follows; ¿customer advanced the needle to desired position and found out the needle cannot be punctured into target area.Customer retracted the device and found out the needle is tipless.Customer also confirmed no device part was remain in patient¿ 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 c1703051 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 c1703051.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".There is no evidence to suggest that the customer did not follow the instructions for use (ifu0101-1).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 device potentially having been damaged in packaging or potentially damaged on removal of the device from the packaging or damage on insertion into the scope resulting in the needle tip breaking.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.

Event Description

The investigation was concluded on the 12-apr-2021, this supplement report is being submitted to include the investigation conclusions within section h.

• 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: 11358227
• MDR Text Key: 244493464
• Report Number: 3001845648-2021-00140
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 10827002315201
• UDI-Public: (01)10827002315201(17)230128(10)C1703051
• 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
• Report Date: 04/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2023
• Device Catalogue Number: ECHO-19
• Device Lot Number: C1703051
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2021
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/21/2020
• Event Location: Hospital
• Date Manufacturer Received: 12/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Weight: 45