MAUDE Adverse Event Report: COOK IRELAND LTD CYSTOTOME CYSTOENTEROSTOMY NEEDLE KNIFE; KNS UNIT, ELECTROSURGICAL, ENDOSCOPIC

Catalog Number CST-10

Device Problem Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/25/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

User advanced the device into patient but found out the needle knife cannot be pulled out, then user took force to pull the needle knife which cause a part of needle knife broken in patient.User then took biospy forceps to remove the broken part of needle knife, then change to another same device to complete the procedure.Patient outcome under confirmation.

Event Description

Supplemental report is being submitted due to the completion of the investigation on 17-apr-2024.

Manufacturer Narrative

Device evaluation 1 unit of lot c1971124 of cst-10 was returned opened in its original packaging.The device related to this occurrence underwent a laboratory evaluation on 22 january 2024.Outer catheter examined and no issues observed.Inner catheter examined and no issues observed.Uncoiling of the spring observed.Small metal piece returned separately.Through the investigation it was confirmed that the small metal part returned separately and observed during the lab evaluation did not belong to the complaint device and was packed into the package by accident.It was also confirmed that the part of the device which was broken during the procedure was discarded by the user facility and not returned to cirl with the rest of the device.Manufacturing records: prior to distribution, all cst-10 devices are subjected to a visual inspection and functional inspection to ensure device integrity.A review of the manufacturing records for cst-10 of lot number c1971124 did not reveal any discrepancies that could have contributed to this complaint issue.Review historical data the review of relevant manufacturing records confirms the failure mode has not previously occurred for this work order.Instructions for use and/label the instructions for use, ifu0005 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 (ifu0005).Image review: an image was not returned for evaluation.Root cause analysis: a definitive root cause could not be determined as the circumstances of use cannot be replicated in the laboratory.A potential root cause is difficult to determine but could be attributed to tortuous anatomy potentially causing the device to be used in a flexed position.This could have caused the difficulty with pulling out the needle knife which in turn may have resulted in extra force to be used leading to the damage/uncoiling to the distal end of the needle knife and causing part of the needle knife to be broken.Summary: complaint is confirmed based on visual and/or functional inspection.No patient outcome information was shared, however it was confirmed in the complaint description that the distal tip of the needle knife was recovered from the patient with a forceps.Complaints of this nature will continue to be monitored for similar events.

• Brand Name: CYSTOTOME CYSTOENTEROSTOMY NEEDLE KNIFE
• Type of Device: KNS UNIT, ELECTROSURGICAL, ENDOSCOPIC
• 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: 17825085
• MDR Text Key: 324360951
• Report Number: 3001845648-2023-00739
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 10827002305509
• UDI-Public: (01)10827002305509(17)250823(10)C1971124
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K022595
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CST-10
• Device Lot Number: C1971124
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/25/2023
• Event Location: Hospital
• Initial Date Manufacturer Received: 08/29/2023
• Initial Date FDA Received: 09/27/2023
• Supplement Dates Manufacturer Received: 08/29/2023
• Supplement Dates FDA Received: 05/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/23/2022
• 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 Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Sex: Female