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 Problem Retraction Problem (1536)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) # k160229.(b)(4).Investigation is pending.A follow up mdr will be submitted with the investigation conclusions.

Event Description

Doctor in this hospital told the rep that they are not longer using these needles as the they tend to damage their scope."as per complaint form": during my conversation with dr (b)(6) on (b)(6) i was told that the dept have stopped using the cook procore ebus needle as it damaged their olympus ebus scope.No other details were given.

Manufacturer Narrative

Pma/510(k) # k160229.Cook ireland ltd (manufacturer) is submitting this report on behalf of (b)(6).Exemption number: e2016031.(b)(4).The echo-hd-22-ebus-o-c device involved in this complaint will not been returned for evaluation.With the limited information provided, a document based investigation was carried out.As the device was not returned for evaluation and conditions of device usage cannot be replicated in the laboratory it is not possible to conclusively determine the root cause of this complaint.The customer complaint is considered confirmed based on customer testimony.Root cause: a possible root cause for this occurrence may be that excessive force may have been used causing the needles to damage scope.As per the additional information received, the hospital do not have the needle as it happen earlier this year and they could not confirm if the damage to the scope was 100% due the needle.The precautions section of the instructions for use ifu0109-4 that accompanies this device instructs the user to inspect the device prior to use for any damage: ¿the needle must be retracted into the sheath and the thumbscrew in the safety ring must be locked at the 0 cm mark to hold the needle in place prior to introduction, advancement or withdrawal of the device.Failure to retract the needle may result in damage to the endoscope.¿ in the instructions for use section it is mentioned; ¿caution: during needle adjustment or extension, ensure the device has been attached to the accessory channel of the endoscope.Failure to attach the device prior to needle adjustment or extension may result in damage to the endoscope.¿ and in the notes section of the instructions for use it is also mentioned 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".Prior to distribution, all echo devices are subjected to functional checks and 100% visual inspection to ensure integrity of the product.These inspections and functional checks are outlined in internal procedures in place at cirl the manufacturing records of the device involved in this complaint could not be reviewed as the lot number of the complaint device was not provided.From the information provided: 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

This follow up mdr is being submitted to include the investigation conclusions.Doctor in this hospital told the rep that they are not longer using these needles as the they tend to damage their scope."as per complaint form": during my conversation with dr (b)(6) on 13th october i was told that the dept have stopped using the cook procore ebus needle as it damaged their olympus ebus scope.No other details were given.

• 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 Contact: michael galvin ; o halloran road; national technology park; limerick ; 061334440
• MDR Report Key: 7013355
• MDR Text Key: 92609003
• Report Number: 3001845648-2017-00522
• Device Sequence Number: 1
• Product Code: FCG
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/09/2017

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 Catalogue Number: ECHO-HD-22-EBUS-O-C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/08/2017
• Event Location: Hospital
• Initial Date Manufacturer Received: 10/17/2017
• Initial Date FDA Received: 11/09/2017
• Supplement Dates Manufacturer Received: 10/17/2017
• Supplement Dates FDA Received: 12/07/2017
• 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