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

Model Number G30550

Device Problems Difficult to Remove (1528); Material Deformation (2976)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 09/02/2019

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) # k022595.Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.

Event Description

Needle knife cannot be removed.Products will be available for examination as per complaint form: "when removing the needle knife from the device, the needle wire got stuck with the welding point between needle knife and wire at the lüer-connection.".

Manufacturer Narrative

The two cst-10 devices of lot number c1618647 involved in this complaint was 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.The device related to this occurrence underwent a laboratory evaluation on the 20sep2019.The needle knife was unable to withdraw from the two devices with normal force.The needle knife was able to be removed with force from both devices.O-ring measured for device 1, 4.327mm(in specification, 4.2mm ¿ 4.7mm ).O-ring measured for device 2, 4.381mm (in specification, 4.2mm ¿ 4.7mm ).Prior to distribution all cystotome cst-10 devices are subject to visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.A review of the relevant manufacturing records (c1618647) revealed no discrepancies that could have contributed to this complaint.Upon review of complaints, this failure mode has not occurred previously with this lot number.There is no evidence to suggest that the customer did not follow the instructions for use (ifu0005-11).A definitive root cause could not be determined as the circumstances of use cannot be replicated in the laboratory.A possible root cause could be attributed to the handle and male luerlock adapter could have been over-tightened causing the o-ring to pinch the tubing.Complaint is confirmed as the failure was verified in the laboratory.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

Needle knife cannot be removed.Products will be available for examination.As per complaint form: "when removing the needle knife from the device, the needle wire got stuck with the welding point between needle knife and wire at the lüer-connection." fda mdr reporting required: event is fda mdr reportable based on the device malfunction reporting precedence for this device family for the issue of ¿inner catheter stuck/difficult to retract'.

Event Description

This is a correction report as the investigation has been updated to reflect changes to the root cause summary previously submitted under emdr 3001845648-2019-00502.Needle knife cannot be removed.Products will be available for examination as per complaint form: "when removing the needle knife from the device, the needle wire got stuck with the welding point between needle knife and wire at the lüer-connection.".

Manufacturer Narrative

This is a correction report as the investigation has been updated to reflect changes to the root cause summary previously submitted under emdr 3001845648-2019-00502.Device evaluation: the two cst-10 devices of lot number c1618647 involved in this complaint was 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.Lab evaluation: the device related to this occurrence underwent a laboratory evaluation on the 20sep2019.The needle knife was unable to withdraw from the two devices with normal force.The needle knife was able to be removed with force from both devices.O-ring measured for (b)(4), 4.327mm(in specification, 4.2mm ¿ 4.7mm ).O-ring measured for (b)(4), 4.381mm (in specification, 4.2mm ¿ 4.7mm ).Document review: prior to distribution all cystotome cst-10 devices are subject to visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl a review of the relevant manufacturing records (c1618647) revealed no discrepancies that could have contributed to this complaint.Upon review of complaints, this failure mode has not occurred previously with this lot number.There is no evidence to suggest that the customer did not follow the instructions for use (ifu0005-11).Root cause review: as per nc19-051 investigation, engineering have determined the root cause is attributed to the outer diameter (od) of external handle threads being too large (out of specification).Due to this od being too large; post assembly of mlla adapter rmn 25-099 onto the threads of handle, the mlla is applying localized pressure to this location.This pressure is squeezing on the o-ring that sits under the mlla onto the inner catheter causing it to pinch resulting in difficulty in movement of the inner wire (needle knife section) past this pinched point.Summary : complaint is confirmed as the failure was verified in the laboratory.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.

• Brand Name: CYSTOTOME CYSTOENTEROSTOMY NEEDLE KNIFE
• Type of Device: KNS UNIT, ELECTROSURGICAL, ENDOSCOPIC
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 9144075
• MDR Text Key: 189902958
• Report Number: 3001845648-2019-00502
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 00827002305502
• UDI-Public: (01)00827002305502(17)220530(10)C1618647
• Combination Product (y/n): N
• PMA/PMN Number: K022595
• 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: 03/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/30/2022
• Device Model Number: G30550
• Device Catalogue Number: CST-10
• Device Lot Number: C1618647
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/02/2019
• Event Location: Hospital
• Date Manufacturer Received: 09/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1