MAUDE Adverse Event Report: COOK IRELAND LTD ECHOTIP PROCORE ENDOBRONCHIAL HD BIOPSY NEEDLE; FCG KIT, NEEDLE, BIOPSY

Catalog Number ECHO-HD-22-EBUS-O-C

Device Problems Break (1069); Use of Device Problem (1670)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/18/2020

Event Type  Injury  

Manufacturer Narrative

510k # : k160229.Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.

Event Description

The needle tip was broken and dislodged from the rest of the needle assembly while pricking the right lower paratracheal lymph node.Tip the needle was seen at carina after breakage and it was removed by the bronchoscope.A section of the device did not remain inside the patient¿s body.Tip the needle was seen at carina after breakage and it was removed by the bronchoscope.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

The needle tip was broken and dislodged from the rest of the needle assembly while pricking the right lower paratracheal lymph node.Tip the needle was seen at carina after breakage and it was removed by the bronchoscope.A section of the device did not remain inside the patient¿s body.Tip the needle was seen at carina after breakage and it was removed by the bronchoscope.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.

Manufacturer Narrative

510k # : k160229.Device evaluation: 1 unit of lot c1557547 of echo-hd-22-ebus-o-c was returned opened in its original packaging.Lab evaluation: the device related to this occurrence underwent a laboratory evaluation on 17 apr 2020.The returned device lab findings and observations can be referred through the attached files.The distal tip of the needle was observed to be broken.Document review including ifu review prior to distribution, all echo-hd-22-ebus-o-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-22-ebus-o-c of lot number c1557547 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 c1557547.The instructions for use, ifu0109-6 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" and "this device is intended for use with an olympus ebus scope".There is evidence to suggest that the customer did not follow the instructions for use in relation to the type of scope used (ifu0109-6) root cause review: a definitive root cause could be attributed to user error as the user used the device with an incompatible device, as per information provided, a fuji scope was used and as per ifu ¿this device is intended for use with an olympus ebus scope¿, therefore the user did not follow the instructions for use.It is not possible to know how the device performs with an incompatible device therefore the distal needle break could have been induced by the scope.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.The broken needle tip was removed by the bronchoscope.Complaints of this nature will continue to be monitored for potential emerging trends.

• Brand Name: ECHOTIP PROCORE ENDOBRONCHIAL HD BIOPSY NEEDLE
• Type of Device: FCG KIT, NEEDLE, BIOPSY
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 10016913
• MDR Text Key: 191127708
• Report Number: 3001845648-2020-00274
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 10827002342818
• UDI-Public: (01)10827002342818(17)211109(10)C1557547
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 05/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/09/2021
• Device Catalogue Number: ECHO-HD-22-EBUS-O-C
• Device Lot Number: C1557547
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2020
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/18/2020
• Event Location: Hospital
• Date Manufacturer Received: 04/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 40 YR
• Patient Weight: 80