MAUDE Adverse Event Report: COOK INC NGAGE NITINOL STONE EXTRACTOR; FFL DISLODGER, STONE, BASKET, URETERAL, METAL

Model Number N/A

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 02/10/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The event is currently under investigation.A follow up report will be send upon conclusion.

Event Description

It was reported by the user facility that a patient underwent a right flexi urs lower calyx,middle calyx and upper calyx procedure.The device in use was an ngage nitinol stone extractor.It was reported that the basket could not opened or closed during the rirs procedure.It was stated that the patient did not require any additional procedures.There were no unintended sections of the device that remained inside of the patient¿s body, nor did the patient experience any adverse effects due to this occurrence.No further information was provided.

Manufacturer Narrative

(b)(4).The event is currently under investigation.A follow up report will be send upon conclusion.Correction: should have shown asku.The reporter provided that the patients were male and female.The reporter stated the patients¿ ages were (b)(6).The reporter also provided the weights of (b)(6).However, it was not clear from the reporter which demographics matched which patient.Lot number should have been 7094526.Please see medwatch numbers 1820334-2017-00433, 1820334-2017-00431, 1820334-2017-00432 for the additional devices from this event.

Event Description

It was reported by the user facility that two patients underwent a right flexi urs lower calyx, middle calyx and upper calyx procedure.The device in use for both procedures was an ngage nitinol stone extractor.The reporter stated that there were four baskets used, all with different lot numbers.There was no information as to which basket was used with which patient or how many were used for each procedure.It was reported that the baskets could not open or close during the rirs procedure.It was stated that the patients did not require any additional procedures.There were no unintended sections of the device that remained inside of either of the patients¿ bodies, nor did the patients experience any adverse effects due to these reported events.No further information was provided.

Manufacturer Narrative

A review of the complaint history, device history, mi, and qc were completed, and visual inspection of the returned device was conducted during the investigation.There is no evidence to suggest the product was not made to specifications.Review of device history record showed one nonconformance for the lot # for this device.It was not related to this failure.There were no other reported complaints for this lot number.The device is shipped with an instruction for use (ifu) that describes the intended use.A functional test showed that the udh handle did actuate the basket formation.A definitive root cause could not be determined.Measures have been previously initiated to address this issue.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.

• Brand Name: NGAGE NITINOL STONE EXTRACTOR
• Type of Device: FFL DISLODGER, STONE, BASKET, URETERAL, METAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: rita harden ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 6394509
• MDR Text Key: 69564906
• Report Number: 1820334-2017-00434
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 00827002482975
• UDI-Public: (01)00827002482975(17)190705(10)7094526
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: NGE-022115
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/10/2017
• Initial Date FDA Received: 03/10/2017
• Supplement Dates Manufacturer Received: Not provided; 06/26/2017
• Supplement Dates FDA Received: 03/10/2017; 07/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/22/2016
• 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: 60 YR
• Patient Weight: 80