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); Retraction Problem (1536)

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

Event Date 08/14/2022

Event Type  malfunction  

Event Description

User opened the package and installed the needle onto endoscopy and adjusted the sheath length, then confirmed the length of needle advancement, user completed puncture but found out the needle cannot be pulled, user retracted the needle from patient and found out the needle broken.User then changed to another same device to complete the procedure."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." if the report involves a kink or bend in the needle, where is this located on the device (handle end or patient end)? no.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.3.5cmx2.5cm what is the endoscope manufacturer and model number that was used with this device? olympus 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? 1.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

510k # k210476.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Manufacturer Narrative

510k # k210476.Cancellation report being submitted based to confirmation received on the 11-oct-2022 that no issue with needle retraction occured.Therefore, reassessed as not reportable as event does not meet criteria of an fda ¿serious injury¿ report or ¿malfunction¿ report as per fda guidelines ¿medical device reporting for manufacturers (2016)¿.

Event Description

Cancellation report being submitted based to confirmation received on the 11-oct-2022 that no issue with needle retraction occured.Therefore, reassessed as not reportable as event does not meet criteria of an fda ¿serious injury¿ report or ¿malfunction¿ report as per fda guidelines ¿medical device reporting for manufacturers (2016)¿.

• 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
• 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: 15543468
• MDR Text Key: 306686409
• Report Number: 3001845648-2022-00689
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 10827002347851
• UDI-Public: (01)10827002347851(17)240422(10)C1821993
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ECHO-HD-3-20-C
• Device Lot Number: C1821993
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/14/2022
• Event Location: Hospital
• Date Manufacturer Received: 09/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/22/2021
• 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: 62 YR
• Patient Sex: Male
• Patient Weight: 58 KG