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 12/22/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

User advanced the device to desired position and complete the first biopsy, but found out the needle cannot be retracted into sheath completely.User tried several times but failed.User retracted the device along with endoscopy and detected the stylet bent.User then changed to another same device to complete the biopsy."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.".

Event Description

Supplemental follow up report is being submitted due to lab evaluation completion on 21-jan-2022: upon visual inspection, it was observed that the needle was exposed on the return.Distal end of needle examined and distal needle kink observed.Upon functional inspection, it was observed that the sheath extender able to advance and retract without any issues, needle able to advance but not able to retract due to the distal kink, attempted to remove stylet but unable to remove due to the distal kink.

Manufacturer Narrative

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

Event Description

Supplemental report is being submitted due to the completion of the investigation.

Manufacturer Narrative

Device evaluation: 1 unit of echo-19 device of lot number c1852713 involved in this complaint was returned for evaluation, in its original packaging.The device related to this occurrence underwent a laboratory evaluation on 21 january 2022.Needle was exposed on the return.Distal end of needle examined and distal needle kink observed sheath extender able to advance and retract without any issues.Needle able to advance but not able to retract due to the distal kink.Attempted to remove stylet but unable to remove due to the distal kink.Prior to distribution, all echo-19 devices are subjected to functional checks and visual inspection to ensure device integrity.A review of the manufacturing records for echo-19 of lot number c1852713 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 c1852713.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).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 lesion being hard and this cause the needle to kink distally.Another possible root cause could be attributed to the device being over torqued causing the needle to kink distally.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; o'halloran road; national technology park; limerick
• Manufacturer Contact: aisling hassett ; o'halloran road; national technology park; limerick ; 061334440
• MDR Report Key: 13304911
• MDR Text Key: 287399975
• Report Number: 3001845648-2022-00032
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 10827002315201
• UDI-Public: (01)10827002315201(17)240723(10)C1852713
• Combination Product (y/n): N
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ECHO-19
• Device Lot Number: C1852713
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2022
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/22/2021
• Event Location: Hospital
• Date Manufacturer Received: 12/24/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/23/2021
• 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
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 59 KG