MAUDE Adverse Event Report: COOK IRELAND LTD ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE; FCG KIT, NEEDLE, BIOPSY

Model Number G31519

Device Problem Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/03/2019

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) # k083330.(b)(4).Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.

Event Description

Impossible to take out the stylet & impossible to advance the needle.As per complaint form : "it is impossible to get inside the lesion and also impossible to put the stylet back inside the needle until the end of the needle.".

Event Description

Impossible to take out the stylet & impossible to advance the needle.As per complaint form : "it is impossible to get inside the lesion and also impossible to put the stylet back inside the needle until the end of the needle.".

Manufacturer Narrative

Pma/510(k) #k083330.Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031 information pertaining (b)(4).Importer site establishment registration number: (b)(4).The device related to this occurrence underwent a laboratory evaluation.Needle was removed from handle during the lab evaluation and observed to be crumpled.This would account for both issues experienced with needle advancement and stylet.Another kink proximal to the sheath extender was also observed.An additional pr was requested to be opened for this.However it was determined that this additional pr could be cancelled after update from rep to confirm that no kinks were observed prior to return of the device.Prior to distribution, all echo-25 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-25 of lot number c1505525 did not reveal any discrepancies that could have contributed to this complaint issue.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 kinked/bent was concluded from the laboratory evaluation.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 hard lesion.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
• MDR Report Key: 8394598
• MDR Text Key: 138146118
• Report Number: 3001845648-2019-00087
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 00827002315198
• UDI-Public: (01)00827002315198(17)210601(10)C1505525
• Combination Product (y/n): N
• PMA/PMN Number: K083330
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Modification/Adjustment
• Type of Report: Initial,Followup
• Report Date: 03/06/2019

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: 06/01/2021
• Device Model Number: G31519
• Device Catalogue Number: ECHO-25
• Device Lot Number: C1505525
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/06/2019
• Event Location: Hospital
• Initial Date Manufacturer Received: 01/10/2019
• Initial Date FDA Received: 03/06/2019
• Supplement Dates Manufacturer Received: 01/10/2019
• Supplement Dates FDA Received: 04/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1