MAUDE Adverse Event Report: COOK IRELAND LTD ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE; FCG KIT, NEEDLE, BIOPSY

Catalog Number ECHO-HD-3-20-C

Device Problem Break (1069)

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

Event Date 09/07/2018

Event Type  malfunction  

Manufacturer Narrative

510 (k) number: k142688.(b)(4).(b)(4).Device evaluation: the echo-hd-3-20-c device of unknown lot number involved in this complaint was returned for evaluation without original packaging.With the information provided, a physical examination and document based investigation was conducted.Additional information was received as follows: if the report involves a kink or bend in the needle, where is this located on the device (handle end or patient end)? - n/a.Please describe the location in the body for the intended target site (pancreas, stomach, etc).- pancreas.Please describe the size of the intended target site.- more than 15mm.What is the endoscope manufacturer and model number that was used with this device? - olympus/ model name unknown.Was gaining access to the targeted site difficult? - no.Was the endoscope in a flexed or twisted position at any time during the procedure? - no.Was needle penetration of the targeted site difficult? - no.Was the stylet in place inside the needle when advancing into the targeted site? - yes.How many biopsies were obtained with use of this needle? - twice.Did any section of the device detach inside the patient? - no.If not with the device in question, how was the procedure performed and/or finished? - another device was used instead.The device related to this occurrence underwent a laboratory evaluation on the 26 september 2018.Proximal needle breakage noted.Break located 140.5cm from tip of needle and 30cm from bottom of hub.Needle specification length is 1705mm +2mm/-2mm.Syringe was missing.Device not working due to needle breakage.Visual inspection was completed.The customer complaint is considered to be confirmed as the failure was verified in the laboratory.Root cause a definitive root cause for the customer complaint could not be determined as the exact operational conditions of use could not be replicated in the laboratory setting.However it is possible that device handling or excessive force was applied causing the needle breakage when attaching or detaching the device to the scope.A capa has been initiated to document and track the actions taken to investigate and to address kinking or breaking of the sheath at the sheath/sheath extender junction.The scope of the capa includes; needle breaking, kinking or crumpling within the handle assembly kinking or breaking of the sheath at the sheath/sheath extender junction.Document review as the echo-hd-3-20-c device lot number is unknown, a review of the relevant manufacturing records cannot be conducted.Prior to distribution, all echo-hd-3-20-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 cirl.Ifu review the notes section of the instructions for use, ifu0077-4, which accompanies this device instructs the user to inspect the device prior to use for any damage: "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 (ifu0077-4 ).Summary according to the initial reporter, the patient did not experience any adverse effects due to this occurrence.The customer complaint is considered to be confirmed as the failure was verified in the laboratory.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

The device was used for eus-fna of the tumour in the pancreatic body.There was no particular tortuosity in the access route.The device could be used with no problem in needle strokes at the first biopsy.After collecting specimen from the first biopsy, the physician attempted the second biopsy as follows; the needle was advanced into the target site, then the physician started needle strokes.However, only the handle could be moved and the needle did not respond to the handle movement.The needle could not be pulled back into the sheath due to the event, so the device was removed from the endoscope with the needle stuck out from the sheath.The procedure was continued with another device and completed successfully.The endoscope was not damaged despite the event.There have been no adverse effects to the patient reported.

• Brand Name: ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND 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: 7933594
• MDR Text Key: 122635660
• Report Number: 3001845648-2018-00469
• Device Sequence Number: 1
• Product Code: FCG
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Report Date: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ECHO-HD-3-20-C
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/04/2018
• Event Location: Hospital
• Date Manufacturer Received: 09/10/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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