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

Model Number G48294

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/25/2019

Event Type  malfunction  

Manufacturer Narrative

Occupation: profession unknown.Pma/510k #: exempt.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

It was originally reported that during a flexible ureteroscopy using a ngage nitinol stone extractor, it was not possible to go as far as the calyx.The surgeon inserted the extractor with the plastic introducer into the ureteroscope, and despite this it did not pass as if it was already twisted.The device wasn't visually broken.They had to use another device to finish the procedure.The patient did not experience any adverse effects as a result of this alleged product malfunction.Upon initial investigation and testing of the returned complaint device, it was found that the device could not be closed properly due to bowing of the protective sheath.

Event Description

There is no new patient or event information to report.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Investigation ¿ evaluation a visual inspection and functional testing of the returned device was conducted.A document based investigation was also performed including a review of complaint history, device history record, the instructions for use(ifu), manufacturing instructions, and quality control data.One device was returned to the manufacturer for investigation.The returned packaging confirms the lot number.The device was returned with the handle and basket formation in the closed position.Mlla [male luer lock adapter] is tight.The collet knob is tight and secure.A visual examination notes the support sheath is bowed in appearance and there is a slight gap when the basket formation is in the closed position.Functional testing determined the handle actuates the basket formation.A review of the device history record found no non-conformance's related to the reported failure mode.A review of complaint history revealed no additional complaints associated with the complaint device lot.The ifu provides the following information to the user related to the reported failure mode: important: excessive force could damage device.Based on the investigation evaluation, there is no indication that a design or process related failure mode contributed to this event.Current controls for manufacturing are in place to assure functionality and device integrity prior to shipping.A 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.To conclude the returned device was found to have a basket that would not fully close.When closed, the basket was observed to have a small gap at the tip of the basket.The gap could have prevented the device from being fed easily down the scope.There was also sheath damage observed, the orange support sheath was bowed in appearance.The sheath damage was preventing the basket from closing fully.The sheath damage likely occurred during handling of the device.All devices are inspected multiple times for damage and functionality during manufacturing.The ifu contains a caution that excessive force can damage the device.The cause is traced to the user.Unintended use error cause or contributed to this issue.Per the quality engineering risk assessment, no further action is warranted.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• 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
• MDR Report Key: 8663654
• MDR Text Key: 147520393
• Report Number: 1820334-2019-01363
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 00827002482944
• UDI-Public: (01)00827002482944(17)220204(10)9498586
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/05/2019

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 Expiration Date: 02/04/2022
• Device Model Number: G48294
• Device Catalogue Number: NGE-017115
• Device Lot Number: 9498586
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2019
• Initial Date Manufacturer Received: 05/10/2019
• Initial Date FDA Received: 06/03/2019
• Supplement Dates Manufacturer Received: 06/10/2019
• Supplement Dates FDA Received: 07/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNSPECIFIED FLEXIBLE URETEROSCOPE