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

Catalog Number NTSE-022115-UDH

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products- boston sci lithovue ureteroscope.(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 during a ureteroscopy laser lithotripsy an ncirlcle tipless stone extractor was used.While extracting the stone, the basket broke in the kidney.A 3.2 alligator was used to retrieve it.The laser and basket were not used in the scope at the same time.No parts of the device remained inside the patient's body as a result of this product problem.The procedure reportedly concluded as normal.

Manufacturer Narrative

Evaluation / investigation: a review of complaint history, device history record, quality control and specifications was performed.A visual inspection of the device was also conducted.One ncircle tipless stone extractor was returned for evaluation.The basket formation has been detached from the coil assembly and the basket was not returned.The collet knob was tight and secure.The male luer lock adaptor (mlla) was tight.The support sheath and the basket sheath remained attached.The coil assembly was found to have an offset coil 1.5 mm from the tip.The distal cannula is also missing.There are no visible wires.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.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.The device history record review was performed.Two nonconformance's were noted; however, both of the units were scrapped.A review of complaint history found there have been no other complaints received for this device lot number.Based on the provided information and the investigation evaluation a definitive root cause for the reported issue could not be determined.Measures have been initiated to address this failure mode.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: 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: 6732655
• MDR Text Key: 80697800
• Report Number: 1820334-2017-01803
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 00827002187788
• UDI-Public: (01)00827002187788(17)200302(10)7717450
• 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,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 12/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: NTSE-022115-UDH
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/02/2017
• 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
• Patient Outcome(s): Required Intervention