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

Catalog Number NGE-022115-MB

Device Problems Break (1069); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/07/2017

Event Type  malfunction  

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 Description

The customer reported during the ureteroscopic lithotripsy (ursl) procedure the physician used an ngage nitinol stone extractor to grasp the stone for the first time.As reported, the connection at the yellow line was broken and the basket wire would not work correctly.The physician chose to use a new ngage nitinol stone extractor to complete the procedure.No section of the device remained inside the patient.No additional procedures were required as a result of this occurrence.There was no adverse consequence or impact to the patient.

Manufacturer Narrative

Investigation - evaluation: a review of the device history record, documentation, drawings, manufacturing instructions, quality control data, and specifications was performed.Visual inspection and functional testing of the returned device was also conducted during the investigation.One ngage nitinol stone extractor was returned for evaluation.The device was returned with the handle and the basket formation partially open.The collet knob is tight and secure.The male luer lock adaptor (mlla) is tight.The polyethylene terephthalate tubing (pett) measures 3 cm in length.A visual examination noted the proximal segment of the support sheath is severed 1.5 cm from the nose of the mlla.The support sheath and the basket sheath are detached.The distal segment of the support sheath measures 2.5 cm up to the point of separation.The distal segment is still attached.The handle does not actuate the basket formation.Kinks were noted on the basket sheath 1.5 cm, 34 cm, and 40 cm from the distal tip.The handle was disassembled.The basket formation could not be manually actuated.There is no indication that a design or process related failure mode contributed to this event.A review of production and quality documentation did not identify any specific issues with current manufacturing or quality controls that may have contributed to this incident.The device history record was reviewed and two non-conformances were identified.The issues identified were loose debris and the wrong inserter.The items with these issues were reworked.A review of complaint history revealed there have been no other complaints associated with complaint device lot number 7845868.Based on the provided information a definitive root cause cannot be established or reported.However, appropriate measures have been initiated to address this failure mode.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.

• 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: 6789039
• MDR Text Key: 82896305
• Report Number: 1820334-2017-02516
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 00827002482968
• UDI-Public: (01)00827002482968(17)200420(10)7845868
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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: 12/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: NGE-022115-MB
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/20/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Weight: 72