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

Model Number G30550

Device Problem Operating System Becomes Nonfunctional (2996)

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

Event Date 04/14/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Two x cst-10 devices of lot # c1-11284 involved in this event.One device was returned and second device was confirmed as discarded by the customer.One x cst-10 device of lot c1011284 was returned to cirl for a lab evaluation.During the lab evaluation the needle knife exited the inner catheter without a problem, there was a kink noted at 7 cm from the handle on the wire and the inked catheter was also kinked after the third ink mark from the distal end of the device.Additional information was requested regarding the steps taken to get the needle tip out of the device; however as of 13/july/2017 this information has not been received.If this additional information is received the complaint file will be updated in line with the response.It should be noted that it is not possible to determine if the kinking on the wire and inked catheter occurred during use or during transportation back to cook (b)(4) for evaluation.Due to the limited information provided by the customer and the fact that the device needle exited and retracted as expected during the lab evaluation and also given that clinical conditions of use could not be replicated in the laboratory evaluation setting it is not possible to determine a root cause for the customer complaint.It is possible that a tortuous anatomy made it difficult for the user to advance the needle knife out of the inked catheter, it is also possible that the kinking on the wire and/ or inked catheter may have reduced the pushability of the needle/ knife if this kinking was present during use, kinking of the wire and / or inked catheter may potentially have occurred if the user advanced the device through the scope with excessive force, however this cannot be conclusively determined as the root cause for the customer complaint.The customer complaint of advancement difficult of the needle knife is confirmed based on customer testimony.The instructions for use, states prior to use to."visually inspect with particular attention to kinks, bends or breaks.If an abnormality is detected that would prohibit proper working condition, do not use".Prior to distribution, all cst-10 devices are subjected to functional checks and visual inspection.The complaint was confirmed based on customer testimony.There was no impact to a patient or end user.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

As reported to customer relations: "the needle knife would not come out of the distal tip.Doc had to remove the device and manually pull out the needle knife, reinserting the cystotome down the scope with the needle knife exposed, which is against ifu this happened with the second device as well.".

Manufacturer Narrative

(b)(4).Exemption number: e2016031.(b)(4).This follow up cancellation mdr is being submitted the risk has been evaluated on file closure and the initial assessment was conservative.Additional information requested; " the below report indicated there were 2 devices and i have been informed only 1 has been returned.Can you let me know the status of the other device? also, the needle extended and retracted without an issue during the lab evaluation on the returned device.Can you find out what steps were taken to get the needle out of the device? was the device uncoiled upon opening prior to use?", however as of 07/sep/2017 it has only been clarified that only one device was saved for return and the other information has not been received.Complaint file will be updated upon receipt of this information.1 x cst-10 device was returned to cirl for a lab evaluation.A lab evaluation was held on 04/may/2017.During the lab evaluation the needle knife exited the inner catheter without a problem, there was a kink noted at 7cm from the handle on the wire and the inked catheter was also kinked after the third ink mark from the distal end of the device.Additional information was requested regarding the steps taken to get the needle tip out of the device and also if the device was uncoiled prior to use/ testing; however as of 07/sep/2017 this information has not been received.If this additional information is received the complaint file will be updated in line with the response.It should be noted that it is not possible to determine if the kinking on the wire and inked catheter occurred during use or during transportation back to cook ireland for evaluation.Due to the limited information provided by the customer and the fact that the device needle exited and retracted as expected during the lab evaluation and also given that clinical conditions of use could not be replicated in the laboratory evaluation setting it is not possible to determine a root cause for the customer complaint.It is possible that the user retracted the needle knife too far which resulted in the catheter and wire kinks which prevented the knife from coming out of the tip it is also possible a tortuous anatomy made it difficult for the user to advance the needle knife out of the inked catheter, it is also possible that the kinking on the wire and/ or inked catheter may have reduced the pushability of the needle/ knife if this kinking was present during use, kinking of the wire and / or inked catheter may potentially have occurred if the user advanced the device through the scope with excessive force, however this cannot be conclusively determined as the root cause for the customer complaint.The customer complaint of advancement difficult of the needle knife is confirmed based on customer testimony.A review of the manufacturing records for the cst-10 devices did not reveal any discrepancies that could have contributed to the complaint issue.The cst-10 cystotome device consists of a proximal electrode, a distal electrode, a diathermic ring, a needle knife, an inner catheter and an outer catheter.The needle knife is manufactured in the sub assembly with the inner catheter.The instructions for use, states prior to use to."visually inspect with particular attention to kinks, bends or breaks.If an abnormality is detected that would prohibit proper working condition, do not use".The complaint was confirmed based on customer testimony.There was no impact to a patient or end user.The overall risk for this complaint has been assessed and determined to be low.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

This follow up cancellation mdr is being submitted the cancel the initial report submitted.The risk has been evaluated following completion of the investigation and the risk has been determined to be low.An initial malfunction report was submitted to err on the side of caution pending investigation completion.No malfunction precedence exists for this device or issue.As reported to customer relations: "the needle knife would not come out of the distal tip.Doc had to remove the device and manually pull out the needle knife, reinserting the cystotome down the scope with the needle knife exposed, which is against ifu this happened with the second device as well.".

• Brand Name: CYSTOTOME CYSTOENTEROSTOMY NEEDLE KNIFE
• Type of Device: KNS UNIT, ELECTROSURGICAL, ENDOSCOPIC
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• Manufacturer Contact: michael galvin ; o halloran road; national technology park; limerick ; 061334440
• MDR Report Key: 6766988
• MDR Text Key: 81832573
• Report Number: 3001845648-2017-00313
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 00827002305502
• UDI-Public: (01)00827002305502(17)170619(10)C1011284
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K022595
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G30550
• Device Catalogue Number: CST-10
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/11/2017
• Event Location: Hospital
• Date Manufacturer Received: 08/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/19/2014
• 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