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 03/22/2017

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 an unspecified procedure using an ngage nitinol stone extractor.The initial report indicated that the customer had experienced a problem with an ngage basket.The customer problem was unidentified by the reporter, however if new information is received a follow up medwatch will be submitted.No further information was provided.

Manufacturer Narrative

Investigation ¿ evaluation: a review of the functional test, instructions for use (ifu), specifications, complaint history, device history record, manufacturing instructions, and quality controls were completed, and visual inspection of the returned device was conducted during the investigation.Review of production and quality documentation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.One device was returned for investigation.The device was returned with the unidex handle (udh) in the closed position and the basket formation was partially open.The udh handle would actuate the basket formation to the fully open, but when closing, the basket formation would only partially close.It was noted that when the handle knob is pushed to the end of the slide, the basket formation closes completely.The collet knob was tight and secure.The support sheath is adhered securely to the basket sheath.The device is shipped with an instruction for use (ifu) that describes the intended use.A visual examination of the device noted the basket sheath has kinks, one at 4 cm from the support sheath and another 33 cm from the support sheath.A review of the non-conformance data revealed 1 non-conformance which was not related to the complaint condition.Based on the provided information a definitive root cause cannot be established or reported at this time.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: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 6511831
• MDR Text Key: 73509625
• Report Number: 1820334-2017-00741
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 00827002482968
• UDI-Public: (01)00827002482968(17)190610(10)7035578
• Combination Product (y/n): N
• Reporter Country Code: GB
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: N/A
• Device Catalogue Number: NGE-022115-MB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/10/2016
• 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