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

Catalog Number	ECHO-25
Medical Device Problem Code	Device Operational Issue (2914)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/19/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Information has currently being requested.Investigation in process.
Event or Problem Description
The sheath adjuster screw would not tighten and kept slipping during the procedure so the device was replaced to complete the procedure.
Additional Manufacturer Narrative
This event was initially assessed as fda mdr reportable based on a conservative assessment that this event met the criteria of an mdr 'malfunction report'.Following the submission of the initial report the risk of this event and failure mode was evaluated resulting in a low risk rating for this event and failure mode.It may be noted also that no injury to the patient has been reported as a result of this event.It is also noted that a reporting malfunction precedence does not exist for this failure mode.Based on the risk assessment carried out relating to this event - this event is no longer fda mdr reportable and does not meet the criteria of an fda mdr 'malfunction' report as per fda guidelines ¿medical device reporting for manufacturers¿.Note method, results and conclusion codes not applicable due to this re-assessment.
Event or Problem Description
This event was initially assessed as fda mdr reportable based on a conservative assessment that this event met the criteria of an mdr 'malfunction report'.Following the submission of the initial report the risk of this event and failure mode was evaluated resulting in a low risk rating for this event and failure mode.It may be noted also that no injury to the patient has been reported as a result of this event.It is also noted that a reporting malfunction precedence does not exist for this failure mode.Based on the risk assessment carried out relating to this event - this event is no longer fda mdr reportable and does not meet the criteria of an fda mdr 'malfunction' report as per fda guidelines 'medical device reporting for manufacturers'.

• Brand Name: ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE
• Common Device Name: FCG KIT, NEEDLE, BIOPSY
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 5659800
• Report Number: 3001845648-2016-00127
• Device Sequence Number: 10767286
• Product Code: FCG
• UDI-Device Identifier: 00827002315198
• UDI-Public: (01)00827002315198(17)181217(10)C1183888
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K083330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2016

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
• Operator of Device: Health Professional
• Device Catalogue Number: ECHO-25
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/19/2016
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/19/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/17/2016
• Supplement Report FDA Received Date: 06/09/2016
• Patient Sequence Number: 1