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

Model Number G34279

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/03/2019

Event Type  Injury  

Manufacturer Narrative

Pma/510(k) #k160229.1 unit of lot number c1609874 of echo-hd-22-ebus-p-c was returned opened not in its original packaging.The device related to this occurrence underwent a laboratory evaluation.The needle was found to be broken distally.Prior to distribution, all echo-hd-22-ebus-p-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 cook (b)(4).A review of the manufacturing records for echo-hd-22-ebus-p-c of lot number c1609874 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 c1609874.The notes section of 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.The failure of needle broken was concluded from the available information.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 a combination of tortuous position, flexed or twisted endoscope position and hard lesion as indicated in the additional information.Complaint is confirmed as the failure was verified in the laboratory and in the images shared.The tip of the needle has been retrieved from the patient with a forceps.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Needle got broken while taking sample from the subcranial region approximately 1.5 cm from the tip.The tip got detached and retrieval through flexible scope using forceps.

• 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
• Manufacturer (Section G): COOK IRELAND LTD; o halloran road; national technology park; limerick
• Manufacturer Contact: heather ryan ; o halloran road; national technology park; limerick ; 061334440
• MDR Report Key: 9144140
• MDR Text Key: 167504975
• Report Number: 3001845648-2019-00500
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 00827002342798
• UDI-Public: (01)00827002342798(17)220501(10)C1609874
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/03/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2022
• Device Model Number: G34279
• Device Catalogue Number: ECHO-HD-22-EBUS-P-C
• Device Lot Number: C1609874
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/03/2019
• Event Location: Hospital
• Initial Date Manufacturer Received: 09/04/2019
• Initial Date FDA Received: 10/02/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2019
• 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 Outcome(s): Required Intervention
• Patient Age: 60 YR