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

Model Number G34281

Device Problems Break (1069); Material Perforation (2205)

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

Event Date 07/11/2018

Event Type  malfunction  

Manufacturer Narrative

510(k) number: k160229.(b)(4).Investigation is still pending, a follow up report will be submitted to include the investigation conclusions.

Event Description

From the customer "shealth was locked, needle advanced to obtain biopsy.Sheath became unlocked and the needle was over advanced.Potential to perforate +/- cause bleeding.Damage to scope was observed, light was diminished.Sent off for repair".The locking screws on the shealth did not lock and moved during first advance of the needle pass.Scope was also damaged.Procedure aborted after no patient bleeding observed.

Manufacturer Narrative

510(k) number: k160229.Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.Information pertaining to mfr site as follows: importer site contact and address: (b)(6).(b)(4).Importer site establishment registration number: (b)(4).Two echo-hd-22-ebus-o-c devices of lot number: c1406911 involved in this complaint were returned for evaluation, with the original packaging.The packaging was open on receipt.With the information provided, a physical examination and document based investigation was conducted.Additional information was received as follows: additional information sheet questions 1.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.2.Please describe the location in the body for the intended target site (pancreas, stomach, etc).Bronchus (ebus).3.Please describe the size of the intended target site.15mm.4.What is the endoscope manufacturer and model number that was used with this device? olympus bf-uc180f broncho fiber video scope.5.Was gaining access to the targeted site difficult? no.6.Was the endoscope in a flexed or twisted position at any time during the procedure? slightly flexed during attempted biopsy.7.Was needle penetration of the targeted site difficult? no.8.Was the stylet in place inside the needle when advancing into the targeted site? yes.9.How many biopsies were obtained with use of this needle? none.10.Did any section of the device detach inside the patient? no.11.If not with the device in question, how was the procedure performed and/or finished? the procedure was aborted.Lab evaluation: two devices, 1 used and 1 unused device related to this occurrence underwent a laboratory evaluation on (b)(6) 2018.Used device: proximal kink noted, likely due to re packaging for transport returns.Adaptor and syringe were not returned.No issues detected on either device.Grooves observed in inner white handle of used device on both, sheath and needle extender halves of handle indicating excessive force.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 possible root cause could be excessive force as there were visible slide marks from the point of locking (indent on the inner handle).Complaint is confirmed based on the customers testimony.Document review: a review of the quality records at incoming inspection did not reveal any discrepancies which could have contributed to this complaint report.Prior to distribution, all echo-hd-22-ebus-o-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.A review of the manufacturing record for echo-hd-22-ebus-o-c device of lot number: c1406911 did not reveal any discrepancies which could have contributed to this complaint report.A non conformance was noted on the work order, however this was subsequently re-worked and would not have attributed to this complaint issue.There is no evidence to suggest that this issue affects the entire lot#: c1406911; upon review of complaints this failure mode has not occurred previously with this lot#: c1406911.Ifu review: it may be noted that according to the instructions for use, ifu0109-5, 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¿.There is no evidence to suggest that the customer did not follow the instructions for use (ifu0109-5).Summary: complaint is confirmed based on the customers testimony.The risk was determined to be low risk (category iia).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

From the customer "sheath was locked, needle advanced to obtain biopsy.Sheath became unlocked and the needle was over advanced.Potential to perforate +/- cause bleeding.Damage to scope was observed, light was diminised.Sent off for repair" the locking screws on the shealth did not lock and moved during first advance of the needle pass.Scope was also damaged.Procedure aborted after no patient bleeding observed.

Manufacturer Narrative

510(k) number: k160229.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).Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.

Event Description

From the customer "shealth was locked, needle advanced to obtain biopsy.Sheath became unlocked and the needle was over advanced.Potential to perforate +/- cause bleeding.Damage to scope was observed, light was diminised.Sent off for repair" the locking screws on the shealth did not lock and moved during first advance of the needle pass.Scope was also damaged.Procedure aborted after no patient bleeding observed.

• Brand Name: ECHOTIP PROCORE ENDOBRONCHIAL HD BIOPSY NEEDLE
• Type of Device: FCG KIT, NEEDLE, BIOPSY
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 7761059
• MDR Text Key: 116389155
• Report Number: 3001845648-2018-00368
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 00827002342811
• UDI-Public: (01)00827002342811(17)201004(10)C1406911
• 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,Followup
• Report Date: 09/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/04/2020
• Device Model Number: G34281
• Device Catalogue Number: ECHO-HD-22-EBUS-O-C
• Device Lot Number: C1406911
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2018
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/08/2018
• Event Location: Hospital
• Date Manufacturer Received: 07/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1