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

Model Number	G34281
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)
Date of Event	11/12/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pma/510(k) #: k160229.Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
The tip of the needle got broken at about 5mm during use.It is not known if some part of the needle was left in the patient.As per complaint form: "taking biopsies from lymph node at tracheobronchial tree (exact place and lymph node station will be given later) they noticed that the tip of the needle was missing.Endoluminal tip was found (length of fragment 5mm) distally from where they punctured in the right lower lobe.".
Additional Manufacturer Narrative
Pma/510(k) # k160229.Complaint device was not returned therefore a document based review will be performed.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 c1619542 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 c1619542.The instructions for use, 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.A definitive root cause could not be determined from the available information.As no additional questions were answered a possible root cause is difficult to determine but could be attributed to advancement into a hard lesion.Complaint is confirmed as the failure was verified in the images.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.The needle's tip was removed from the patient.Complaints of this nature will continue to be monitored for potential emerging trends.
Event or Problem Description
The tip of the needle got broken at about 5mm during use.It is not known if some part of the needle was left in the patient.As per complaint form: "taking biopsies from lymph node at tracheobronchiial tree (exact place and lymph node station will be given later) they noticed that the tip of the needle was missing.Endoluminal tip was found (length of fragment 5mm) distally from where they punctured in the right lower lobe.".
Event or Problem Description
The tip of the needle got broken at about 5mm during use.It is not known if some part of the needle was left in the patient.As per complaint form: "taking biopsies from lymph node at tracheobronchiial tree (exact place and lymph node station will be given later) they noticed that the tip of the needle was missing.Endoluminal tip was found (length of fragment 5mm) distally from where they punctured in the right lower lobe.".
Additional Manufacturer Narrative
Pma/510(k) # k160229.Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.

• Brand Name: ECHOTIP PROCORE ENDOBRONCHIAL HD BIOPSY NEEDLE
• Common Device Name: FCG KIT, NEEDLE, BIOPSY
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 9437457
• Report Number: 3001845648-2019-00696
• Device Sequence Number: 14186389
• Product Code: FCG
• UDI-Device Identifier: 00827002342811
• UDI-Public: (01)00827002342811(17)220605(10)C1619542
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/05/2022
• Device Model Number: G34281
• Device Catalogue Number: ECHO-HD-22-EBUS-O-C
• Device Lot Number: C1619542
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/12/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 11/12/2019
• Supplement Date Received by Manufacturer: 11/12/2019; 11/12/2019
• Initial Report FDA Received Date: 12/09/2019
• Supplement Report FDA Received Date: 01/06/2020; 02/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention