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

Catalog Number ECHO-HD-22-EBUS-O

Device Problems Break (1069); Fracture (1260); Use of Device Problem (1670)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/04/2022

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) # k160229.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

As initially reported to customer relations via email: during an ebus on (b)(6), a cytology needle tip broke off and it wasn¿t realized until the mdr was reprocessing the scope.1.Did any unintended section of the device remain inside the patient¿s body? no if yes, please describe.2.Was the patient hospitalized or was there prolonged hospitalization? no 3.Did the patient require any additional procedures due to this occurrence? pt declined so no further if yes, please describe.4.Did the product cause or contribute to the need for additional procedures? no if yes, please specify additional procedures and provide details.5.Has the complainant reported any adverse effects on the patient due to this occurrence? no 6.Has the complainant reported that the product caused or contributed to the adverse effects? no please specify adverse effects and provide details.Echo 4.1 for all complaints, ask: are images of the device or procedure available? no.If the report involves a kink or bend in the needle, where is this located on the device (handle end (proximal end) or patient end (distal end))? patient end-- needle tip bent and broke off.Were any other defects (other than the complaint issue) observed on the device prior to return (e.G.Kink)? no.Please specify if yes.If the device was kinked below the sheath extender, was the kink observed before inserting the device into the scope? no.If the device is a procore needle, is the device damage located at the notch / core trap? yes if no, please specify where the damage is located: unknown (per customer) was gaining access to the target site difficult? no.Was the device used in a tortuous position? no.Was puncture of the target site difficult? no.Please describe the anatomical location of the intended target site (pancreas, stomach, lungs etc.).Lungs if the lungs, which lymph node was being targeted? e.G.4r, 11r, 12l etc.7 please describe the size of the intended target site.1cm if not with the device in question, how was the procedure performed and/or finished? scope used to complete procedure as needle break was unknown until mdr.Effected needle was removed from scope, inspected and another needle used to do 2 more core passes at stn 7.Was the device damaged in packaging prior to removal? no.Was the device damaged on removal from packaging? no.Was force required to remove the device? no.Did the patient require any additional procedures as a result of this event? no.What intervention (if any) was required? pt declined an outpatient x-ray.

Event Description

Supplemental follow-up report is being submitted due to the completion of the investigation and an update to the investigation conclusions on the 23-may-2022.

Manufacturer Narrative

Pma/510(k) # k160229 device evaluation complaint device was not returned therefore a document based review will be performed.Lab evaluation n/a document review including ifu review prior to distribution, all echo-hd-22-ebus-o 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-hd-22-ebus-o of lot number c1900984 did not reveal any discrepancies that could have contributed to this complaint issue.The review of relevant manufacturing records confirms the failure mode has not previously occurred with the current lot number.Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with lot number c1900984.The notes section of the instructions for use, ifu0051-9, which accompanies this device instructs the user to inspect the device prior to use: "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 (ifu0051-9).Image review n/a root cause review a definitive root cause could not be determined from the available information.A possible root cause could be attributed to damage on insertion into the scope resulting in the needle tip breaking as it was confirmed that the scope was damaged by the needle.Summary complaint is confirmed based on customer¿s testimony.According to the initial reporter, the patient did not experience adverse effects due to this occurrence.The broken needle tip was recovered by the mdr department during reprocessing of the scope.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Supplemental report is being submitted as a correction report due to new information received 12-jul-2022.Information received 12-jul-2022: i spoke to the rep and i can confirm that the scope used was manufactured by fuji.We don¿t know the model or the condition of the scope.Supplemental follow-up report is also being submitted due to the completion of the investigation and an update to the investigation conclusions.

Manufacturer Narrative

Pma/510(k) # k210476.Device evaluation: complaint device was not returned therefore a document based review will be performed.Clarification was requested as follows: ¿can you please ask if the broken needle tip involved with this complaint was recovered?¿ reply was received as follows: ¿yes it was recovered by the mdr department during reprocessing.The scope itself was damaged by the needle, 41k in repairs.¿ the following information was received from the global product manager: ¿i spoke to the rep and i can confirm that the scope used was manufactured by fuji.We don¿t know the model or the condition of the scope." lab evaluation: n/a.Document review including ifu review: prior to distribution, all echo-hd-22-ebus-o 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-hd-22-ebus-o of lot number c1900984 did not reveal any discrepancies that could have contributed to this complaint issue.The review of relevant manufacturing records confirms the failure mode has not previously occurred with the current lot number.Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with lot number c1900984.The notes section of the instructions for use, ifu0051-9, which accompanies this device instructs the user to inspect the device prior to use: "visually inspect with particular attention to kinks, bends and breaks.If an abnormality is detected that would prohibit proper working condition, do not use¿ and "this device is intended for use with an olympus ebus scope".There is evidence to suggest that the customer did not follow the instructions for use in relation to the type of scope used (ifu0051).Image review: n/a.Root cause review: a definitive root cause could be attributed to user error as the user used the device with an incompatible device, as per information provided, a fuji scope was used and as per ifu ¿this device is intended for use with an olympus ebus scope¿, therefore the user did not follow the instructions for use.It is not possible to know how the device performs with an incompatible device therefore the distal needle break could have been induced by the scope.Summary: complaint is confirmed based on customer¿s testimony.According to the initial reporter, the patient did not experience adverse effects due to this occurrence.The broken needle tip was recovered by the mdr department during reprocessing of the scope.Complaints of this nature will continue to be monitored for potential emerging trends.

• Brand Name: ECHOTIP ULTRA ENDOBRONCHIAL HD 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: sinead o'leary ; o halloran road; national technology park; limerick
• MDR Report Key: 14356045
• MDR Text Key: 299964992
• Report Number: 3001845648-2022-00268
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 10827002520117
• UDI-Public: (01)10827002520117(17)250106(10)C1900984
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ECHO-HD-22-EBUS-O
• Device Lot Number: C1900984
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/04/2022
• Event Location: Hospital
• Date Manufacturer Received: 04/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/06/2022
• 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
• Patient Age: 67 YR
• Patient Sex: Female