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

Catalog Number	NGRE-100038
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/21/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A follow up report will be submitted upon receipt of additional information or completion of the investigation.
Event or Problem Description
The user facility reported during a right percutaneous nephrolithotomy procedure, while using the perc ngage nitnol tipless stone extractor, the handle locked in position and the device would not retract back from the sheath.The wiring started to unravel and fell apart.The device was removed and they proceeded with a new basket and completed the procedure successfully.No adverse effects or consequences were reported to the patient due to this occurrence.No unintended portion of the device remained inside the patient¿s body.No additional procedures were required due to this occurrence.
Additional Manufacturer Narrative
Investigation - evaluation: a review of documentation, drawing, functional testing, manufacturing instructions, specifications, drawings, instructions for use (ifu), quality control data, and visual inspection of the actual device was conducted during the investigation.The returned device was found to be non-functional due to damage to the basket assembly.The wires of the basket are deformed and there is damage to the ends of the sheaths that house the wires.All devices are 100% inspected for functionality and integrity before packaging.The ifu contains a caution to not use excessive force to manipulate the device, or damage to the device may occur.It is also possible that the strength of the basket was weakened due to variation in the manufacturing process.There is not enough information to determine which of the two possible causes is more likely, therefore the cause of the issue could not be determined.Current controls are in place in manufacturing to assure device functionality prior to shipping.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.There is no indication that a design or process related failure mode contributed to this event.Based on the available information, the root cause of this event is undeterminable.Per the quality engineering risk assessment, no further action is required.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.

• Brand Name: PERC NGAGE NITINOL TIPLESS STONE EXTRACTOR
• Common Device Name: FFL DISLODGER, STONE, BASKET, URETERAL, METAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7132727
• Report Number: 1820334-2017-04333
• Device Sequence Number: 13962530
• Product Code: FFL
• UDI-Device Identifier: 00827002564015
• UDI-Public: (01)00827002564015(17)200802(10)8110718
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2018

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
• Operator of Device: Health Professional
• Device Catalogue Number: NGRE-100038
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/21/2017
• Supplement Date Received by Manufacturer: 01/26/2018
• Initial Report FDA Received Date: 12/19/2017
• Supplement Report FDA Received Date: 02/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1