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

Model Number G31520

Device Problems Break (1069); Material Deformation (2976)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 07/31/2018

Event Type  malfunction  

Manufacturer Narrative

510(k) number: k083330.(b)(4).(b)(6).Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.

Event Description

The user opened the package and check the integrity of the device and found out the tip of the sheath broken.

Manufacturer Narrative

510 (k) number: k083330.Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.Importer site contact and address: (b)(6).Cook medical incorporated (cmi) (b)(6).Importer site establishment registration number: (b)(4).This follow up report is being submitted to cancel the initial report submitted.Initially this report was conservatively assessed as a proximal sheath kink that has a risk associated with it that is not remote.Upon receipt of the device the sheath was damaged distally and no kink was confirmed therefore the updated failure mode assigned is categorized as low risk and therefore no longer meets the fda malfunction reporting criteria.No precedence exists for this event and no patient injury occurred.

Event Description

This follow up report is being submitted to cancel the initial report submitted.Initially this report was conservatively assessed as a proximal sheath kink that has a risk associated with it that is not remote.Upon receipt of the device the sheath was damaged distally and no kink was confirmed therefore the updated failure mode assigned is categorized as low risk and therefore no longer meets the fda malfunction reporting criteria.No precedence exists for this event and no patient injury occurred.

• Brand Name: ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE
• Type of Device: FCG KIT, NEEDLE, BIOPSY
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; national technology park; limerick
• MDR Report Key: 7821899
• MDR Text Key: 118393954
• Report Number: 3001845648-2018-00401
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 00827002315204
• UDI-Public: (01)00827002315204(17)210412(10)C1474489
• 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
• Type of Report: Initial,Followup
• Report Date: 08/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/12/2021
• Device Model Number: G31520
• Device Catalogue Number: ECHO-19
• Device Lot Number: C1474489
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2018
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/24/2018
• Event Location: Hospital
• Date Manufacturer Received: 08/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1