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 Problems Fracture (1260); Material Deformation (2976); Physical Resistance/Sticking (4012)

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

Event Date 03/17/2021

Event Type  malfunction  

Event Description

User detected the conjunction area between handle and sheath twisted after 3 puncture which cause advancement and retraction of needle difficulty.User then changed to another same lot# device to continue the procedure while the same issue occurred that the conjunction area between handle and sheath twisted after 3 puncture.User again changed to another same device to complete the procedure.Additional information received 31-mar-2021: the needle cannot be fully retracted into the sheath prior to removal from the patient."a section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence." for complaints occurring during use (once in contact with endoscope) also ask: if the report involves a kink or bend in the needle, where is this located on the device (handle end or patient end)? handle end.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.28mm*28.5mm 28mm*28.5mm.What is the endoscope manufacturer and model number that was used with this device? olympus gf-uct260, gf-uct260.Was gaining access to the targeted site difficult? no.Was the endoscope in a flexed or twisted position at any time during the procedure? yes.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? 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? with another same device to complete the procedure.

Manufacturer Narrative

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

Event Description

The device was evaluated on the (b)(6) 2021 and the investigation was concluded on the (b)(6) 2021, this supplement report is being submitted to include the updated information in section d and h.

Manufacturer Narrative

510(k) number: k142688.2 units of lot c1658535 of echo-hd-3-20-c was returned opened in the original packaging.Lab evaluation: the device involved in the complaint was evaluated in the laboratory on (b)(6) 2021.A proximal break was observed below the sliding sheath extender on device 1.A proximal break was observed below the sliding sheath extender on device 2.Document review including ifu review: 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 a review of the manufacturing records for echo-hd-3-20-c of lot number c1780786 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 c1780786.The notes section of the instructions for use, ifu0077-4 which accompanies this device instructs the user to; "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).A definitive root cause for the customer complaint could not be determined as circumstances of use cannot be replicated in the laboratory.A possible cause could be attributed to flexed or twisted endoscope position as indicated in the additional information.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.Complaint is confirmed as the failure was verified in the laboratory.According to the initial reporter, the patient did experience any adverse effects due to this occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.

• 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: 11669762
• MDR Text Key: 280539377
• Report Number: 3001845648-2021-00312
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 10827002347851
• UDI-Public: (01)10827002347851(17)231126(10)C1780786
• 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: 04/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/26/2023
• Device Catalogue Number: ECHO-HD-3-20-C
• Device Lot Number: C1780786
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2021
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/17/2021
• Event Location: Hospital
• Date Manufacturer Received: 03/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 62