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

Catalog Number NTSE-022115-UDH

Device Problem Material Separation (1562)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 12/07/2017

Event Type  Injury  

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 while performing a bilateral ureteroscopy w/ laser lithotripsy that during the extraction of the stone, when the basket met the ureteral access sheath, the physician went to pull the basket through the access sheath and the tip of the basket broke off.The reporter stated that there was no lithotripsy being used at the time the basket was in use.It was further reported that there was swelling at the uretero pelvic junction, making it difficult to pull the stone into the access sheath.The basket tip was retrieved with a 3 prong grasper.Another basket was used to complete the procedure.No unintended section of the device remained inside of the patient.There were no further adverse effects to the patient from this event.

Manufacturer Narrative

Investigation - evaluation.A review of documentation, drawings, functional testing, manufacturing instructions, specifications, quality control data, and visual inspection of the returned device was conducted during the investigation.The basket formation has been severed from the coil assembly.The complaint was confirmed based on the investigation of returned device.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 provided information, inspection of returned product, and the investigation, a definitive root cause cannot be established or reported at this time.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
• MDR Report Key: 7139051
• MDR Text Key: 95528339
• Report Number: 1820334-2017-04344
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 00827002187788
• UDI-Public: (01)00827002187788(17)200830(10)8185094
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 02/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2017
• 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
• Date Manufacturer Received: 01/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR