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

Catalog Number NTSE-022115-UDH

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

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 the ncircle tipless stone extractor's handle disconnected while in use.No adverse effects or consequences were reported to the patient due to this occurrence.

Manufacturer Narrative

One device was returned for investigation.The device was returned with the handle in the open position.The collet knob is tight and secure.The mlla (male luer lock adaptor) is loose.The pett measures 2.5 cm in length.The handle is severed from the basket sheath and basket assembly.With the handle in the open position, there is 1.5 cm of cannulated handle protruding from the mlla.The support sheath is severed at the nose of the mlla.The handle actuates the remaining cannulated handle.The proximal end of the basket assembly, 3.7 cm of the support sheath is still attached.There is 1.8 cm of the basket sheath protruding from the proximal end of the support sheath.There is 9.1 cm of the basket coil extending beyond the basket sheath on the proximal end.A visual examination noted kinks in the basket sheath at the following locations; 25.5 cm from the distal tip of the basket sheath, again at 30 cm, 91 cm, and 101.5 cm from the distal tip.The basket assembly was removed from the basket sheath, the basket formation was found to be intact and symmetrical.There is a small kink between the distal cannula and the coil assembly.All the pieces of the device have been returned.No patient harm was reported.There is no indication that a design or process related failure mode contributed to this event.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.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; device integrity prior to shipping.Based on the provided information a definitive root cause cannot be established or reported at this time.We will notify the appropriate personnel and continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.

• Brand Name: NCIRCLE TIPLESS 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: 7147591
• MDR Text Key: 96063864
• Report Number: 1820334-2017-04608
• Device Sequence Number: 1
• Product Code: FFL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NTSE-022115-UDH
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/31/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/17/2017
• 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