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

Model Number G55736

Device Problems Bent (1059); Kinked (1339)

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

Event Date 02/14/2018

Event Type  malfunction  

Manufacturer Narrative

The 510(k) number: k142688.(b)(4).Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

Needle kinked, very difficult to take the sample because stylet couldn¿t be introduce customer succeed to take the sample with water and stopped examination after only one passage.No problem for the patient "as per complaint form": nurse opened the needle package and removed it from the box without problem.Dr connected needle on the scope it was a little difficult because he was in a difficult position into duodenal bulb doctor "punctionned", and removed the needle from the scope.They tried to take the sample but needle was impossible to slide into the sheath; the handle moved but the needle tip stayed fixed.They could inset the stylet inside and they decided to push water inside the needle for pushing the sample into the pot, they could obtain material into the pot and decided to stop examination.For the customer the needle is disconnected from the handle.No problem for the patient.

Manufacturer Narrative

510(k) number: k142688.Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.Information pertaining (b)(4).Importer site establishment registration number: (b)(4).It may be noted that it was initially stated in the customer complaint form; "hey saw the tip of the needle planted in stomach wall (you can see it on the picture attached) doctor could remove it with a biopsy forcep without any problem for the patient and the scope" however, upon further investigation this information was found to be incorrect and the customer complaint form was updated to reflect this.Lab evaluation: 1 x echo-hd-22-c device of lot #c1432716 was returned to cirl for evaluation.Upon evaluation the device was returned in a plastic bag.The stylet was fully in place and there was no needle exposure.The needle was able to retract and advance.There was a proximal kink below the sheath extender.The stylet was difficult to re- introduce but it was able to move past the kink with a little force.No other functional issues were noted with the device.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 the kink occurred upon attachment/ detachment from the scope as the location of the kink is where the device attaches to the scope.Capa (b)(4) was raised in relation to this issue and it will deal with any actions identified.Documents review: prior to distribution, all echo-hd-22-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: it may be noted that according to the instructions for use, ifu0077-4, the user is instructed to: ¿visually inspect with particular attention to kinks, bends and breaks.If any abnormality is detected that would prohibit proper working condition, do not use¿.A review of the manufacturing records for echo-hd-22-c of lot number c1432716 did not reveal any discrepancies that could have contributed to this complaint issue.A review of the information provided, indicates the ifu has been followed.There is no evidence to suggest that this issue affects the entire lot # c1432716 upon review of complaints this failure mode has not occurred previously with this lot # c1432716.Summary: from the information provided, no adverse effects to the patient have been reported as a result of this occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Needle kinked, very difficult to take the sample because stylet couldn¿t be introduce customer succeed to take the sample with water and stopped examination after only one passage.No problem for the patient."as per complaint form": nurse opened the needle package and removed it from the box without problem.Dr connected needle on the scope it was a little difficult because he was in a difficult position into duodenal bulb doctor punctionned, and removed the needle from the scope they tried to take the sample but needle was impossible to slide into the sheath; the handle moved but the needle tip stayed fixed they could inset the stylet inside and they decided to push water inside the needle for pushing the sample into the pot, they could obtain material into the pot and decided to stop examination.For the customer the needle is disconnected from the handle.No problem for the patient.

• 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
• MDR Report Key: 7330840
• MDR Text Key: 102448775
• Report Number: 3001845648-2018-00119
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 00827002557369
• UDI-Public: (01)00827002557369(17)201215(10)C1432716
• Combination Product (y/n): N
• 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: 03/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G55736
• Device Catalogue Number: ECHO-HD-22-C
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/12/2018
• Event Location: Hospital
• Date Manufacturer Received: 02/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1