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

Model Number G31520

Device Problem Retraction Problem (1536)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4) (b)(6).Device evaluation: the echo-19 device of lot number c1463108 involved in this complaint was not available for evaluation.With the information provided, a document based investigation was conducted.The customer complaint is confirmed based on customer testimony.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)?no obvious kink.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.Unknown.If not with the device in question, how was the procedure performed and/or finished? another needle.What is the endoscope manufacturer and model number that was used with this device? olympus linear eus scope.Was difficulty experienced while retracting the needle? yes.Was the needle able to be fully retracted before removing from the patient? no.Was gaining access to the targeted site difficult? moderately.Was the endoscope in a flexed or twisted position at any time during the procedure? at times.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? 2.Did any section of the device detach inside the patient? no.Root cause: a possible root cause could be due to difficulties experienced during the procedure because the device may have been in a twisted or flexed position, noted in additional information received.Additionally another possible root cause could be due to excessive applied during the procedure.The notes section of the instructions for use ifu0101-0 that 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 (ifu0101-0).Document review: a review of the qc records did not reveal any issues which could have contributed to this complaint issue.Prior to distribution, all echo-19 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-19 device of lot# c1463108 did not reveal any discrepancies that could have contributed to this complaint issue.There is no evidence to suggest that this issue affects the entire lot # c1463108; upon review of complaints this failure mode has not occurred previously with this lot # c1463108.Summary: the customer complaint is confirmed based on customer testimony.The risk associated with this complaint is risk category iia/low risk level.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.

Event Description

Needle failed to retract.Unfortunately the needle was discarded so cannot be returned "as per complaint form": needle failed to retract despite it being back at zero dr thought something broke in the handle?this was after 2nd pass and was very carefully withdrawn back into the endoscope customer did not report any damage to the endoscope needle was discarded as dirty and very sharp.

• Brand Name: ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND 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: 7624294
• MDR Text Key: 112001301
• Report Number: 3001845648-2018-00283
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 00827002315204
• UDI-Public: (01)00827002315204(17)210312(10)C1463108
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K083330
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/12/2021
• Device Model Number: G31520
• Device Catalogue Number: ECHO-19
• Device Lot Number: C1463108
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/19/2018
• Event Location: Hospital
• Date Manufacturer Received: 05/25/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/12/2018
• 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