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

Model Number N/A

Device Problem Bent (1059)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 06/20/2017

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

It was reported that prior to performing a procedure the operator noticed that the basket of an ngage nitinol stone extractor was bent severely.The device did not come in contact with the patient.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Investigation ¿ evaluation: one ngage nitinol stone extractor was received for an evaluation.The device was returned with the handle in the closed position and the basket in the closed position.A visual examination noted the basket sheath has a kink located at 22-23 cm from the distal tip of the support sheath.The polyethylene terephthalate tubing (pett) measured 3.7 cm in length.The collet knob was tight and secure.The male luer lock adaptor (mlla) was tight.The support sheath and basket sheath appear to still be adhered.A functional test was performed and found the unidex handle (udh) does not actuate the basket assembly.The complaint was confirmed.Based on the investigation evaluation, 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.A review of the device history record for this device/lot showed there were no non-conformances during the manufacturing process.A review of complaint history for this product/lot number combination revealed no other complaints have been received.The definitive root cause of this device issue could not be determined.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: 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: 6720650
• MDR Text Key: 80255755
• Report Number: 1820334-2017-01596
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 00827002482944
• UDI-Public: (01)00827002482944(17)200328(10)7783007
• Combination Product (y/n): N
• Reporter Country Code: CN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2017
• 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-017115
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/28/2017
• 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