MAUDE Adverse Event Report: COOK IRELAND LTD ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE; FCG KIT, NEEDLE, BIOPSY

Catalog Number ECHO-HD-3-20-C

Device Problems Break (1069); Structural Problem (2506); Material Integrity Problem (2978)

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

Event Date 04/19/2021

Event Type  malfunction  

Event Description

The sheath near the handle got teared and stuck in the channel and fail to complete procedure with procore 20.Currently no adverse effects to the patient reported.

Manufacturer Narrative

510(k) number: k142688.The investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Manufacturer Narrative

510(k) number: k142688.The investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

Supplemental follow-up report is being submitted due to the evaluation of the complaint device.Device was evaluated on 16-jul-2021.Sheath was damaged below the sheath extender.

Manufacturer Narrative

510(k) number: k142688.Device evaluation: 1 unit of echo-hd-3-20-c device of lot number c1607084 involved in this complaint was returned for evaluation, not in the original packaging it should be noted that this file is related to another complaint files.For details of the other investigations please refer to mdr ref #3001845648-2021-00609.The device related to this occurrence underwent a laboratory evaluation on 16 jul 20121 the sheath was observed to be damaged below the sheath extender document review including ifu review.Prior to distribution, all echo-hd-3-20-c 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-hd-3-20-c of lot number c1607084 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 c1607084.The notes section of the instructions for use, ifu0077-4, which accompanies this device instructs the user to inspect the device prior to use: "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 the user did not follow the ifu.(ifu0077-4).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 excessive force which can be applied when trying to get the needle out of the scope during retraction.This could potentially have led to the sheath damage.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.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

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

Manufacturer Narrative

Device evaluation 1 unit of echo-hd-3-20-c device of lot number c1607084 involved in this complaint was returned for evaluation, not in the original packaging it should be noted that this file is related to another complaint files.For details of the other investigations please refer to pr 337651.Lab evaluation the device related to this occurrence underwent a laboratory evaluation on 16 jul 20121 the sheath was observed to be damaged below the sheath extender document review including ifu review prior to distribution, all echo-hd-3-20-c 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-hd-3-20-c of lot number c1607084 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 c1607084.The notes section of the instructions for use, ifu0077-4, which accompanies this device instructs the user to inspect the device prior to use: "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 the user did not follow the ifu.(ifu0077-4) root cause review 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 excessive force which can be applied when trying to get the needle out of the scope during retraction.This could potentially have led to the sheath damage.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.

Event Description

Supplemental report is being submitted due to the completion of the investigation on 20-oct-2022.

• Brand Name: ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE
• Type of Device: FCG KIT, NEEDLE, BIOPSY
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• Manufacturer (Section G): WILLIAM COOK EUROPE; sandet 6, dk-4632; national technology park; bjaeverskov
• Manufacturer Contact: lissi walmann ; sandet 6, dk-4632; national technology park; bjaeverskov
• MDR Report Key: 11839905
• MDR Text Key: 280890542
• Report Number: 3001845648-2021-00390
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 10827002347851
• UDI-Public: (01)10827002347851(17)220424(10)C1607084
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/24/2022
• Device Catalogue Number: ECHO-HD-3-20-C
• Device Lot Number: C1607084
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 07/14/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/19/2021
• Event Location: Hospital
• Initial Date Manufacturer Received: 04/19/2021
• Initial Date FDA Received: 05/18/2021
• Supplement Dates Manufacturer Received: 04/19/2021; 04/19/2021; 04/19/2021
• Supplement Dates FDA Received: 08/13/2021; 09/22/2021; 11/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/24/2019
• 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: 68 KG